18 jobs found for biotechnology pharmaceutical

filter2
clear all
    • lugano, ticino
    • temporary
    Do you have experience acting as an engineer in the Medical Device industry ? Would you like to have the quality engineering oversight of a manufacturing site ? You should then read the following lines!  One of our client, specializing in Medical Devices and based in the Lugano area, is looking for a Senior Quality Engineer for the year 2022 (extendable).Tasks:  Act as a quality engineering representative to improve and maintain products and processes, including validation, risk management, product quality issue resolution and critical issue, and quality systems performance monitoringSupport the Product Release Monitoring and Strategic Collaborator Employee Certification ProgramReview and approve key quality records as they relate to medical devices products in accordance to the Quality Agreement, such as: Nonconformance records (incl. Investigations, CAPA’s and Product Dispositions), Site VMP and Validation protocols, Inspection plans and associated sampling strategiesCoordinate Medical Devices review of nonconformance disposition in collaboration with other required functions (such as Franchise Quality, Regulatory Affairs, etc.)Support Strategic Collaborators Quality and Manufacturing Engineering on the resolution of quality issues impacting Medical devices and coordinates additional subject matter expert supportInitiate Stop Shipments and Product Issue EscalationsSupport improvement plans to address below-target metrics and negative trendsPartner with SC on Recall Prevention and External Audit Readiness initiativesServe as the Source Quality Manager deputy Profile:A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field 4 - 6 years related experience preferred Relevant background in manufacturing/operationsExperience with a consistent track record of implementing appropriate risk mitigationTechnical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.Good technical understanding of manufacturing equipment and processes is requiredStrong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision-makingAbility to perform "hands on" troubleshooting and problem solvingExperience working in both an FDA and European regulatory environment is preferredUnderstanding of the NPI (New Product Introduction) process and Process Validation expertise is preferredThorough understanding of GMP/ISO regulations and validation regulations is preferredQuality Engineering Certifications are a plus (e.g. ASQ CQE, PMI PMP, 6-Sigma, etc.)Business Fluent English and Italian required Does that sound interesting and relevant to you ? Do not waste a minute and apply now then! 
    Do you have experience acting as an engineer in the Medical Device industry ? Would you like to have the quality engineering oversight of a manufacturing site ? You should then read the following lines!  One of our client, specializing in Medical Devices and based in the Lugano area, is looking for a Senior Quality Engineer for the year 2022 (extendable).Tasks:  Act as a quality engineering representative to improve and maintain products and processes, including validation, risk management, product quality issue resolution and critical issue, and quality systems performance monitoringSupport the Product Release Monitoring and Strategic Collaborator Employee Certification ProgramReview and approve key quality records as they relate to medical devices products in accordance to the Quality Agreement, such as: Nonconformance records (incl. Investigations, CAPA’s and Product Dispositions), Site VMP and Validation protocols, Inspection plans and associated sampling strategiesCoordinate Medical Devices review of nonconformance disposition in collaboration with other required functions (such as Franchise Quality, Regulatory Affairs, etc.)Support Strategic Collaborators Quality and Manufacturing Engineering on the resolution of quality issues impacting Medical devices and coordinates additional subject matter expert supportInitiate Stop Shipments and Product Issue EscalationsSupport improvement plans to address below-target metrics and negative trendsPartner with SC on Recall Prevention and External Audit Readiness initiativesServe as the Source Quality Manager deputy Profile:A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field 4 - 6 years related experience preferred Relevant background in manufacturing/operationsExperience with a consistent track record of implementing appropriate risk mitigationTechnical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.Good technical understanding of manufacturing equipment and processes is requiredStrong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision-makingAbility to perform "hands on" troubleshooting and problem solvingExperience working in both an FDA and European regulatory environment is preferredUnderstanding of the NPI (New Product Introduction) process and Process Validation expertise is preferredThorough understanding of GMP/ISO regulations and validation regulations is preferredQuality Engineering Certifications are a plus (e.g. ASQ CQE, PMI PMP, 6-Sigma, etc.)Business Fluent English and Italian required Does that sound interesting and relevant to you ? Do not waste a minute and apply now then! 
    • solothurn, solothurn
    • contract
    Do you want to work in a big medical devices company? Do you have experience in Project Management for Medical Devices? You should then read the following lines! Our client, based in the Solothurn area, is looking for a Project Manager - Regulatory Affairs for a one year contract. Job Description:Support MDR compliance execution work by acting as project manager who has oversight on ongoing MDR compliance work for Trauma/CMF/BIO and drives completion of MDR deliverables. This activity includes but is not limited to:- Coordinate and drive resolving of NB questions to submitted Technical Documentation- Provide regular status updates on MDR compliance progress for Trauma/CMF/BIO to MDR PMO and governance team.- Facilitate resolving of roadblocks and timeline constraints- Support execution of project plan for MDR compliance in Trauma/CMF/BIO business for 2021/ 2022.- Lead regular status update meetings with corresponding teams who are working on individual MDR files and/ or specific topics- Lead and track cross-functional activities as assigned, such as MDR Indication definition and Technical Documentation submissions to Notified Body- Provide project management support for activities needed in preparation for MDR compliance as instructed and assigned. What we need from the candidate:• At least 2 years Project Management experience within Medical Device industry• Basic understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745).• Excellent person interaction skills and reliable and goal oriented work attitude• Experienced skills in MS Office, especially in MS Project• Strong analytical skills• Fluent in English. German in addition, would be an asset. Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. 
    Do you want to work in a big medical devices company? Do you have experience in Project Management for Medical Devices? You should then read the following lines! Our client, based in the Solothurn area, is looking for a Project Manager - Regulatory Affairs for a one year contract. Job Description:Support MDR compliance execution work by acting as project manager who has oversight on ongoing MDR compliance work for Trauma/CMF/BIO and drives completion of MDR deliverables. This activity includes but is not limited to:- Coordinate and drive resolving of NB questions to submitted Technical Documentation- Provide regular status updates on MDR compliance progress for Trauma/CMF/BIO to MDR PMO and governance team.- Facilitate resolving of roadblocks and timeline constraints- Support execution of project plan for MDR compliance in Trauma/CMF/BIO business for 2021/ 2022.- Lead regular status update meetings with corresponding teams who are working on individual MDR files and/ or specific topics- Lead and track cross-functional activities as assigned, such as MDR Indication definition and Technical Documentation submissions to Notified Body- Provide project management support for activities needed in preparation for MDR compliance as instructed and assigned. What we need from the candidate:• At least 2 years Project Management experience within Medical Device industry• Basic understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745).• Excellent person interaction skills and reliable and goal oriented work attitude• Experienced skills in MS Office, especially in MS Project• Strong analytical skills• Fluent in English. German in addition, would be an asset. Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. 
    • zug, zug
    • temporary
    Do you have a first experience with complaint handling ? Do you want to participate in the development of a new complaint handling strategy in a multinational environment ? You should then read the following lines!One of our clients, a renowned life science company based in the Zug area, is looking for a new member for their Technical Production Complaint team. They offer a mission of 9 months at first, with the possibility of extension. Tasks:Assess current post market activities to understand scope of how feedback is received, captured, trended and fed back into various teams and assess gaps against various Medical Device and combination product requirements utilizing current gap analysis and by interviewing customer interfacing teamsCollaborate with quality and regulatory to align on the approach to take going forward, regarding feedback gatheringWork with customer interfacing teams to establish processes required and ensure implementation in the QMS for the applicable Medical Device product (Konektom, MSPT, titration device (Peg IM, Avonex)) in line with the expectations of ISO13485 and EU Medical Device RegulationWork with TPC team to ensure correct implementation of feedback loop from Use error and feedback to allow correct classification, trending and input into usability, performance and safety requirements Work with TD/ PPD to ensure correct implementation of updated design control and risk management procedures through translating TPC feedback data to design/ risk management documents for medical devices and combination devices The mentioned tasks sound appealing to you ? Do not waste a second then, and apply now!
    Do you have a first experience with complaint handling ? Do you want to participate in the development of a new complaint handling strategy in a multinational environment ? You should then read the following lines!One of our clients, a renowned life science company based in the Zug area, is looking for a new member for their Technical Production Complaint team. They offer a mission of 9 months at first, with the possibility of extension. Tasks:Assess current post market activities to understand scope of how feedback is received, captured, trended and fed back into various teams and assess gaps against various Medical Device and combination product requirements utilizing current gap analysis and by interviewing customer interfacing teamsCollaborate with quality and regulatory to align on the approach to take going forward, regarding feedback gatheringWork with customer interfacing teams to establish processes required and ensure implementation in the QMS for the applicable Medical Device product (Konektom, MSPT, titration device (Peg IM, Avonex)) in line with the expectations of ISO13485 and EU Medical Device RegulationWork with TPC team to ensure correct implementation of feedback loop from Use error and feedback to allow correct classification, trending and input into usability, performance and safety requirements Work with TD/ PPD to ensure correct implementation of updated design control and risk management procedures through translating TPC feedback data to design/ risk management documents for medical devices and combination devices The mentioned tasks sound appealing to you ? Do not waste a second then, and apply now!
    • basel, basel-stadt
    • contract
    Do you want to work in a big pharmaceutical company? Do you have experience in leading regulatory submissions? You should then read the following lines! Our client, based in Basel, is looking for a Senior Global Program Regulatory Manager for a 6 months contract. The Senior Global Program Regulatory Manager works independently under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team (GPT) representative and/or GTAL for programs through development, registration and approval/post approval. The Sr GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team (GPT) representative and/or GTAL. In certain cases, the GPRM may be the GPT representative. The Sr GPRM is a member of the DRA sub team and may indirectly report to the DRA GPT representative for the project and has responsibility for leading regional RA sub teams. Major Accountabilities: Regulatory Strategy1. Responsible for implementing regulatory strategy and managing operational activities for assigned regions.2. Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.3. Partners with regions to align on regulatory strategy in order to fulfil business objectives4. Implements RFP across assigned regions.5. Works with RA GPT representative and/or GTAL to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy.6. Works with RA GPT representative and/or GTAL to interact with regulatory consultants/advisors for global strategic input and challenge.7. Develops and implements regulatory readiness with other line functions, Country Pharma8. Organizations and key opinion leaders, and ensures integration with global regulatory readiness with RA GPT representative and/or GTAL.9. Represents RA on or leads sub-teams as required. HA Interactions1. Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL.2. Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.3. Develops and implements plans for timely response to HA requests and coordinates responses.4. Leads rehearsals for HA meetings as appropriate.5. Leads HA meetings independently or with RA GPT representative and/or GTAL as appropriate.6. May serve as local HA liaison depending on location (e.g., FDA or EMA). Submissions and Approvals1. Implements strategy across regions in line with global strategy.2. Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval.3. Proposes options to minimize risk.4. Drives coordination, planning, and submission of dossiers in assigned regions worldwide.5. Review of global dossier summary documents.6. Develops and implements plans to avoid/minimize clock stops during submission review.7. Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).8. Reviews and submits Risk Management Plans.9. May lead negotiations for regional approvals independently or with RA GPT representatives and/or GTAL.10. Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the RA GPT representative and/or GTAL. Prescribing Information1. Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with RA GPT representative and/or GTAL, consistent with development data and commercial objectives of the TPP.2. Generates local PIs, ensuring that they are integrated with the CDS, TPP and regulatory strategy, and are commercially competitive.3. Identifies potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning.4. Revises label as needed to achieve timely HA approval with best possible label based on data available.5. Responsible for ensuring necessary updates or required reviews of local labeling and to capture deviations to maintain alignment with the CDS in conjunction with RA GL. Regional Excellence and Compliance1. Responsible for finalization and on time submission of annual reports and renewals across assigned regions.2. Responsible for appropriate entering and quality of product specific attributes in the compliance database.3. Ensures regulatory compliance for assigned projects and keeps records of all major HA interactions in the validated document management system.4. Ensures quality and compliance with global regulatory requirements (regions responsible) and adherence to regulatory internal policies and processes.5. Provide support as needed for non-project related regional excellence activities. Promotional/Non-promotional Review1. Reviews promotional and non-promotional materials and press releases as required and work with RA GPT representative and/or GTAL to ensure messages are consistent with Novartis policies and guidelines.  Key Performance Indicators: 1. Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.2. Identification of main HA issues for Seed Document.3. Participation in relevant Regulatory Boards leading to valuable input from these Boards.4. Successful participation in HA interactions to achieve business objectives.5. Provides comprehensive regulatory feedback to achieve global business objectives.  Requirements: EducationScience based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Experience• Strong knowledge of regulatory submission and approval processes in 1 or more major regions.• Experience leading regulatory submissions and approvals in at least 1 major region.• Experience in HA negotiations.• 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas:o Innovation in regulatory strategy.o Prior history with post-marketing/brand optimization strategies and commercial awareness preferred.o Involvement in dossier submissions and approvals.o Proven ability to analyze and interpret efficacy and safety data.o Regulatory operational expertise. Do not waste any minutes, apply now! We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    Do you want to work in a big pharmaceutical company? Do you have experience in leading regulatory submissions? You should then read the following lines! Our client, based in Basel, is looking for a Senior Global Program Regulatory Manager for a 6 months contract. The Senior Global Program Regulatory Manager works independently under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team (GPT) representative and/or GTAL for programs through development, registration and approval/post approval. The Sr GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team (GPT) representative and/or GTAL. In certain cases, the GPRM may be the GPT representative. The Sr GPRM is a member of the DRA sub team and may indirectly report to the DRA GPT representative for the project and has responsibility for leading regional RA sub teams. Major Accountabilities: Regulatory Strategy1. Responsible for implementing regulatory strategy and managing operational activities for assigned regions.2. Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.3. Partners with regions to align on regulatory strategy in order to fulfil business objectives4. Implements RFP across assigned regions.5. Works with RA GPT representative and/or GTAL to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy.6. Works with RA GPT representative and/or GTAL to interact with regulatory consultants/advisors for global strategic input and challenge.7. Develops and implements regulatory readiness with other line functions, Country Pharma8. Organizations and key opinion leaders, and ensures integration with global regulatory readiness with RA GPT representative and/or GTAL.9. Represents RA on or leads sub-teams as required. HA Interactions1. Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL.2. Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.3. Develops and implements plans for timely response to HA requests and coordinates responses.4. Leads rehearsals for HA meetings as appropriate.5. Leads HA meetings independently or with RA GPT representative and/or GTAL as appropriate.6. May serve as local HA liaison depending on location (e.g., FDA or EMA). Submissions and Approvals1. Implements strategy across regions in line with global strategy.2. Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval.3. Proposes options to minimize risk.4. Drives coordination, planning, and submission of dossiers in assigned regions worldwide.5. Review of global dossier summary documents.6. Develops and implements plans to avoid/minimize clock stops during submission review.7. Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).8. Reviews and submits Risk Management Plans.9. May lead negotiations for regional approvals independently or with RA GPT representatives and/or GTAL.10. Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the RA GPT representative and/or GTAL. Prescribing Information1. Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with RA GPT representative and/or GTAL, consistent with development data and commercial objectives of the TPP.2. Generates local PIs, ensuring that they are integrated with the CDS, TPP and regulatory strategy, and are commercially competitive.3. Identifies potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning.4. Revises label as needed to achieve timely HA approval with best possible label based on data available.5. Responsible for ensuring necessary updates or required reviews of local labeling and to capture deviations to maintain alignment with the CDS in conjunction with RA GL. Regional Excellence and Compliance1. Responsible for finalization and on time submission of annual reports and renewals across assigned regions.2. Responsible for appropriate entering and quality of product specific attributes in the compliance database.3. Ensures regulatory compliance for assigned projects and keeps records of all major HA interactions in the validated document management system.4. Ensures quality and compliance with global regulatory requirements (regions responsible) and adherence to regulatory internal policies and processes.5. Provide support as needed for non-project related regional excellence activities. Promotional/Non-promotional Review1. Reviews promotional and non-promotional materials and press releases as required and work with RA GPT representative and/or GTAL to ensure messages are consistent with Novartis policies and guidelines.  Key Performance Indicators: 1. Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.2. Identification of main HA issues for Seed Document.3. Participation in relevant Regulatory Boards leading to valuable input from these Boards.4. Successful participation in HA interactions to achieve business objectives.5. Provides comprehensive regulatory feedback to achieve global business objectives.  Requirements: EducationScience based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Experience• Strong knowledge of regulatory submission and approval processes in 1 or more major regions.• Experience leading regulatory submissions and approvals in at least 1 major region.• Experience in HA negotiations.• 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas:o Innovation in regulatory strategy.o Prior history with post-marketing/brand optimization strategies and commercial awareness preferred.o Involvement in dossier submissions and approvals.o Proven ability to analyze and interpret efficacy and safety data.o Regulatory operational expertise. Do not waste any minutes, apply now! We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    • neuchâtel, neuchâtel
    • temporary
    Pour notre client actif dans le domaine médical près de Neuchâtel, nous sommes à la recherche d'un Manufacturing Engineer.Il s'agit d'une mission temporaire jusqu’à fin Juin 2022 avec une (prolongation probable jusqu’à fin déc 2022. Vos tâches:- Vous mettez au point des processus, vous recherchez des paramètres, faites le Design of experiments;- Vous rédigez des procédures opérationnelles, former des opérateurs sur les équipements et processus;- Vous validez les équipements et processus, IQ-OQ PQ et prenez des décisions concernant des choix techniques sur les projets;       - Vous assurez le support de production pour le démarrage en production;- Vous analysez les problèmes. Vous définissez les solutions et les actions et mettez en place un plan d'actions;- Vous faites de la gestion et traitement des non-conformités (NC-NR).Votre profil: - Vous avez un bachelor universitaire dans le domaine médical, mécanique ou microtechnique.- Vous avez de l'expérience dans le monde médical et dans les validations.- Si vous avez de l'expérience en gestion de projet, c'est un gros atout.- Vous parlez et écrivez bien l'anglais.  - Vous connaissez les GMP et la validation de procédés.  
    Pour notre client actif dans le domaine médical près de Neuchâtel, nous sommes à la recherche d'un Manufacturing Engineer.Il s'agit d'une mission temporaire jusqu’à fin Juin 2022 avec une (prolongation probable jusqu’à fin déc 2022. Vos tâches:- Vous mettez au point des processus, vous recherchez des paramètres, faites le Design of experiments;- Vous rédigez des procédures opérationnelles, former des opérateurs sur les équipements et processus;- Vous validez les équipements et processus, IQ-OQ PQ et prenez des décisions concernant des choix techniques sur les projets;       - Vous assurez le support de production pour le démarrage en production;- Vous analysez les problèmes. Vous définissez les solutions et les actions et mettez en place un plan d'actions;- Vous faites de la gestion et traitement des non-conformités (NC-NR).Votre profil: - Vous avez un bachelor universitaire dans le domaine médical, mécanique ou microtechnique.- Vous avez de l'expérience dans le monde médical et dans les validations.- Si vous avez de l'expérience en gestion de projet, c'est un gros atout.- Vous parlez et écrivez bien l'anglais.  - Vous connaissez les GMP et la validation de procédés.  
    • basel, basel-stadt
    • temporary
    Do you wish to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative ?For our client, this pioneering biotechnology company, we are looking for a: Senior Associate, International Manufacturing Operations Location:BaselContract: Temporary for one year. This role is an exciting opportunity to be part of a growing Supply Chain/Manufacturing group. Reporting to Director of International Manufacturing, the successful candidate will work closely with the CMO manufacturing function and Supply Chain function to ensure that the SAP operations are accurate, on track, and in line with GMP compliance and regulatory requirements.Your Responsibilities: Weekly open order book management in collaboration with Manufacturing/Supply Chain in the CMO. The objective is to ensure that the CMO is on track to deliver all released process orders, on-time and in-full. Risks, Opportunities and Issues should be raised and resolved daily.  Daily, or Weekly, Toll material reconciliation process to ensure: All usage of company-owned toll manufacturing materials, by the CMO, is reconciled and accounted for, and that investigations are performed when reconciliation results are outside pre-defined thresholds. That material usage, and inventory transactions, at the CMO are accurately reflected in the SAP system, in a timely way. This can be achieved either through company/CMO system interfaces, or through a manual toll-reconciliation process owned by the Planner.  Execute good receipt and inventory movement transactions required to ensure cross system inventory placement / inventory accuracy Execute the regular raw materials booking within the open process orders in line with CMOs information.Executed Process Orders TECO once that the process orders operations are completed  Ensure compliance with GMP and regulatory requirements (including records management) and spearheads continuous improvements for quality financial flow processes. Your profile:Bachelor level degree in Supply Chain, Business or related field  Between 2 and 3 years of experience in the manufacturing Site preferably as Batch Record Reviewer  Experience in Operation of a highly regulated industry, like Pharmaceutical or related field.  Experience executing SAP Process Orders Raw Materials consumption/Booking .  Ability to manage multiple topics in a fast-paced environment and deal with different stakeholders from different domains in the organization.  Demonstrated ability to critically think and identify solutions.  Well organized – a natural ability to be organized in how you think, communicate and conduct your work  A curious mindset that allows you to constantly learn and challenge the status quo You would like to contribute to a fast-thinking and innovative company, changing the industry ? Apply nowPlease note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position
    Do you wish to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative ?For our client, this pioneering biotechnology company, we are looking for a: Senior Associate, International Manufacturing Operations Location:BaselContract: Temporary for one year. This role is an exciting opportunity to be part of a growing Supply Chain/Manufacturing group. Reporting to Director of International Manufacturing, the successful candidate will work closely with the CMO manufacturing function and Supply Chain function to ensure that the SAP operations are accurate, on track, and in line with GMP compliance and regulatory requirements.Your Responsibilities: Weekly open order book management in collaboration with Manufacturing/Supply Chain in the CMO. The objective is to ensure that the CMO is on track to deliver all released process orders, on-time and in-full. Risks, Opportunities and Issues should be raised and resolved daily.  Daily, or Weekly, Toll material reconciliation process to ensure: All usage of company-owned toll manufacturing materials, by the CMO, is reconciled and accounted for, and that investigations are performed when reconciliation results are outside pre-defined thresholds. That material usage, and inventory transactions, at the CMO are accurately reflected in the SAP system, in a timely way. This can be achieved either through company/CMO system interfaces, or through a manual toll-reconciliation process owned by the Planner.  Execute good receipt and inventory movement transactions required to ensure cross system inventory placement / inventory accuracy Execute the regular raw materials booking within the open process orders in line with CMOs information.Executed Process Orders TECO once that the process orders operations are completed  Ensure compliance with GMP and regulatory requirements (including records management) and spearheads continuous improvements for quality financial flow processes. Your profile:Bachelor level degree in Supply Chain, Business or related field  Between 2 and 3 years of experience in the manufacturing Site preferably as Batch Record Reviewer  Experience in Operation of a highly regulated industry, like Pharmaceutical or related field.  Experience executing SAP Process Orders Raw Materials consumption/Booking .  Ability to manage multiple topics in a fast-paced environment and deal with different stakeholders from different domains in the organization.  Demonstrated ability to critically think and identify solutions.  Well organized – a natural ability to be organized in how you think, communicate and conduct your work  A curious mindset that allows you to constantly learn and challenge the status quo You would like to contribute to a fast-thinking and innovative company, changing the industry ? Apply nowPlease note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position
    • basel, basel-stadt
    • contract
    Do you want to work in a big pharmaceutical company? Do you have some experience in RA CMC? You should then read the following lines! Our client, based in Basel, is looking for a Regulatory Affairs CMC Senior Manager for a mission until december 2022. Job Purpose:Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies. Major Activities: 1.Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.2.Prepare CMC responses to health authority questions during development, registration and product lifecycle.3.Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.4.Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.5.Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.6.Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.7.Establish and maintain sound working relationships with partners and customers.8.Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions). Ideal Background:- Education (minimum/desirable):Minimum:Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalentDesirable:Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent. - Languages: Fluent English required (oral and written).Good skills in site (local) language desired (oral) - Experience/Professional requirement:1.Regulatory experience preferred, and/or experience in drug/biopharmaceuticals2.Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.3.Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.4.Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.5.Effective planning, organizational and interpersonal skills.6.Reasonable approach to risk assessment.7.Excellent written/spoken communication and negotiation skills.8.Computer literacy. Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. 
    Do you want to work in a big pharmaceutical company? Do you have some experience in RA CMC? You should then read the following lines! Our client, based in Basel, is looking for a Regulatory Affairs CMC Senior Manager for a mission until december 2022. Job Purpose:Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies. Major Activities: 1.Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.2.Prepare CMC responses to health authority questions during development, registration and product lifecycle.3.Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.4.Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.5.Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.6.Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.7.Establish and maintain sound working relationships with partners and customers.8.Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions). Ideal Background:- Education (minimum/desirable):Minimum:Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalentDesirable:Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent. - Languages: Fluent English required (oral and written).Good skills in site (local) language desired (oral) - Experience/Professional requirement:1.Regulatory experience preferred, and/or experience in drug/biopharmaceuticals2.Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.3.Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.4.Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.5.Effective planning, organizational and interpersonal skills.6.Reasonable approach to risk assessment.7.Excellent written/spoken communication and negotiation skills.8.Computer literacy. Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. 
    • monthey, vaud
    • permanent
    Vous avez de l'expérience dans une entreprise pharmaceutique ou chimique en tant que responsable de laboratoire? Vous êtes un expert dans les techniques HPLC-GC? Vous allez être intéressé(e) par ce nouveau poste !Nous cherchons un Responsable Laboratoire QC pour une entreprise internationale située proche de Monthey.Vos responsabilités: - Vous allez encadrer une équipe de 4 personnes au sein du laboratoire QC.- Vous gérez toutes les demandes liées au laboratoire.- Vous êtes responsable de faire respecter les exigences de qualité, sécurité et d'environnement et de coûts financiers.- Vous prévoyez la planification quotidienne des analyses en accord avec les besoins de la production et de la vente.- Vous effectuez le contrôle des résultats analytiques du QC.- Vous rédigez les investigations et déviations, les instructions de travail et les procédures.- Vous participez aux séances de coordination avec la production et votre équipe.- Vous participez aux audits internes et externes et aux actions correctives.Votre profil:- Vous avez minimum un CFC en tant que laborant en chimie.- Vous avez au moins 5 ans d'expérience en tant que responsable QC avec une gestion d'équipe.- Vous êtes un référent technique dans les analyses HPLC - GC.Offre:Nous vous proposons un CDI dans une entreprise internationale chimique située près de Monthey.  
    Vous avez de l'expérience dans une entreprise pharmaceutique ou chimique en tant que responsable de laboratoire? Vous êtes un expert dans les techniques HPLC-GC? Vous allez être intéressé(e) par ce nouveau poste !Nous cherchons un Responsable Laboratoire QC pour une entreprise internationale située proche de Monthey.Vos responsabilités: - Vous allez encadrer une équipe de 4 personnes au sein du laboratoire QC.- Vous gérez toutes les demandes liées au laboratoire.- Vous êtes responsable de faire respecter les exigences de qualité, sécurité et d'environnement et de coûts financiers.- Vous prévoyez la planification quotidienne des analyses en accord avec les besoins de la production et de la vente.- Vous effectuez le contrôle des résultats analytiques du QC.- Vous rédigez les investigations et déviations, les instructions de travail et les procédures.- Vous participez aux séances de coordination avec la production et votre équipe.- Vous participez aux audits internes et externes et aux actions correctives.Votre profil:- Vous avez minimum un CFC en tant que laborant en chimie.- Vous avez au moins 5 ans d'expérience en tant que responsable QC avec une gestion d'équipe.- Vous êtes un référent technique dans les analyses HPLC - GC.Offre:Nous vous proposons un CDI dans une entreprise internationale chimique située près de Monthey.  
    • zug, zug
    • contract
    Wir suchen für unseren Partner, ein Quality Manager und Local Safety Officer  Allgemeine Informationen: • Startdatum: asap• Spätestmögliches Startdatum: 16.10.2021• Enddatum: 6 Monate nach Start• Verlängerung: möglich• Arbeitsplatz: Rotkreuz• Workload: 100%Aufgaben & Verantwortlichkeiten: • Kontaktstelle zu Behörden sowie Überwachung und Umsetzung von Safety Cases in Zusammenarbeit mit diesen.• Planung und Organisation von internen sowie externen Audits und Umsetzen der daraus resultierenden Korrekturmassnahmen.• Verantwortlich für die Audit Prozesse inkl.  Überwachung und Aufrechterhaltung.• Erstellt den jährlichen Auditprogramm inkl. Messgrössen zur Überprüfung des Auditprozesses.• Erstellt, definiert und unterhält einen Quality System Review Prozess inkl. Auswertung des Reviews.• Stellt sicher, dass der Abweichungs- inkl. CA/PA Prozess den Anforderungen entspricht.• Stellt sicher, dass ein angemessener Affiliate Notification Prozess erstellt wird. Dabei ist sicherzustellen, dass die geforderten Aktionen der verschiedenen Arten von Notifications adäquat umgesetzt werden inkl. der korrekten Dokumentation.• Entwickelt zielgruppenorientierte Strategien und Konzepte, wie Vorgaben zu Vigilanz und Complaint-Management effizient und effektiv in der Organisation implementiert werden können (Verkauf, CSC, Service ADM).• Erstellt differenzierte Trainingskonzepte (Service, Verkauf, Innendienst) für Complaint-Management / Vigilanz (insbesondere PRI/PSI).• Etabliert und führt ein leistungsfähiges Monitoring- und Reportingsystem zur Transparenz der Performance, Erkennung von Abweichungen und Verbesserungspotenzial und passt diese permanent geänderten Anforderungen an. • Beschreibt und etabliert Prozesse mit Arbeitsanweisungen zum Complaint-Management und zu regulatorisch/meldepflichtig Produktinformations-und Produktrückruf-Prozessen (Field-Safety-Corrective-Actions)• Verantwortlich für die Umsetzung von Affiliate Notifications mit besonderem Fokus auf Safety Board Notifications (SBN) und Quality Notifications (QN) in der Schweiz und Liechtenstein Must Haves: • 3-5 Jahre Berufserfahrung im Bereich ISO 9001, 13485 und Post Market Surveillance, mit Complaint Management und der Kommunikation mit den national zuständigen Behörden – swiss medic• 3-5 Jahre Berufserfahrung im Bereich Quality Management Medical Devices, mit Quality Management Systemen, internen und externen Audits sowie der erforderlichen Dokumentation• Grundkenntnisse in IVDR• Sehr gute Deutschkenntnisse (C1) und gute Englischkenntnisse (mind. B2) Nice to haves: • Erfahrung im Bereich Supplier Quality Management• Erfahrung im Bereich regulatorische Zulassungen EU/SchweizHaben wir dein Interesse geweckt? Dann bewerbe dich über '' jetzt bewerben'' und sende uns deine Bewerbungsunterlagen zu.
    Wir suchen für unseren Partner, ein Quality Manager und Local Safety Officer  Allgemeine Informationen: • Startdatum: asap• Spätestmögliches Startdatum: 16.10.2021• Enddatum: 6 Monate nach Start• Verlängerung: möglich• Arbeitsplatz: Rotkreuz• Workload: 100%Aufgaben & Verantwortlichkeiten: • Kontaktstelle zu Behörden sowie Überwachung und Umsetzung von Safety Cases in Zusammenarbeit mit diesen.• Planung und Organisation von internen sowie externen Audits und Umsetzen der daraus resultierenden Korrekturmassnahmen.• Verantwortlich für die Audit Prozesse inkl.  Überwachung und Aufrechterhaltung.• Erstellt den jährlichen Auditprogramm inkl. Messgrössen zur Überprüfung des Auditprozesses.• Erstellt, definiert und unterhält einen Quality System Review Prozess inkl. Auswertung des Reviews.• Stellt sicher, dass der Abweichungs- inkl. CA/PA Prozess den Anforderungen entspricht.• Stellt sicher, dass ein angemessener Affiliate Notification Prozess erstellt wird. Dabei ist sicherzustellen, dass die geforderten Aktionen der verschiedenen Arten von Notifications adäquat umgesetzt werden inkl. der korrekten Dokumentation.• Entwickelt zielgruppenorientierte Strategien und Konzepte, wie Vorgaben zu Vigilanz und Complaint-Management effizient und effektiv in der Organisation implementiert werden können (Verkauf, CSC, Service ADM).• Erstellt differenzierte Trainingskonzepte (Service, Verkauf, Innendienst) für Complaint-Management / Vigilanz (insbesondere PRI/PSI).• Etabliert und führt ein leistungsfähiges Monitoring- und Reportingsystem zur Transparenz der Performance, Erkennung von Abweichungen und Verbesserungspotenzial und passt diese permanent geänderten Anforderungen an. • Beschreibt und etabliert Prozesse mit Arbeitsanweisungen zum Complaint-Management und zu regulatorisch/meldepflichtig Produktinformations-und Produktrückruf-Prozessen (Field-Safety-Corrective-Actions)• Verantwortlich für die Umsetzung von Affiliate Notifications mit besonderem Fokus auf Safety Board Notifications (SBN) und Quality Notifications (QN) in der Schweiz und Liechtenstein Must Haves: • 3-5 Jahre Berufserfahrung im Bereich ISO 9001, 13485 und Post Market Surveillance, mit Complaint Management und der Kommunikation mit den national zuständigen Behörden – swiss medic• 3-5 Jahre Berufserfahrung im Bereich Quality Management Medical Devices, mit Quality Management Systemen, internen und externen Audits sowie der erforderlichen Dokumentation• Grundkenntnisse in IVDR• Sehr gute Deutschkenntnisse (C1) und gute Englischkenntnisse (mind. B2) Nice to haves: • Erfahrung im Bereich Supplier Quality Management• Erfahrung im Bereich regulatorische Zulassungen EU/SchweizHaben wir dein Interesse geweckt? Dann bewerbe dich über '' jetzt bewerben'' und sende uns deine Bewerbungsunterlagen zu.
    • geneva, genève
    • permanent
    Do you wish to be part of a high-growth, transformational company that is Bold, Innovative, Curious, and Collaborative ?For our client, a pioneering life science company, we are looking for a: Quality Assurance ManagerLocation: GenevaPermanent position You will report directly to the Chief Operating Officer. In this role, you are in charge of coordinating and supporting the implementation of the Quality Management System, ensuring compliance with industry best practices and applicable standards and in developing the company quality culture by providing guidance to management and employees on quality-related questions.  Your Responsibilities:   Key Quality representative o Actively contribute to the development and continuous improvement of Quality Management System o Act as key contact point for quality topics within the organization, providing guidance to laboratories and support functionso Promote quality culture across the organisation o Report Key Quality Indicators to management  Documentation management system o Coordinate the implementation and maintenance of documentation system (including procedures, SOPs, forms and templates) o Ensure documents are handled in accordance with applicable standards, Good Documentation Practices and procedures o Support laboratory staff and support functions in the implementation, monitoring and improvement of quality processes Quality processes Develop, implement and maintain quality processes (e.g. documentation control, handling of incidents, change management) o Contribute to the development and implementation of other processes, providing guidance to teams (e.g. process definition, creation of related documentation) o Review and assess quality-relevant information (e.g. as part of incident management, change management or Vendor qualification processes), as appropriate o Provide training to employees on quality processes and procedures Auditso Perform regular quality audits (“spot checks”) to monitor compliance to internal procedures and applicable standards. o Act as quality representative during customer audits – collect information and prepare answers to qualification and audit questionnaires, accompany customers during on-site audits. Your profile: Education / Experience o University degree in Biology/Biochemistry/Chemistry or Pharmacy o 4-8 years of experience in Quality Assurance in pharmaceutical, biotechnology or health sciences industry o Practical experience of quality management systems – experience in research and development field is an asset o Good knowledge of pharmaceutical guidelines, standards and best practices  Skills / Knowledge o Good communication skills - including writing, speaking and training/teaching skills o Proven organizational skills, ability to handle multiple priorities o Ability to work independently as well as in a team environment o Ability to collaborate and develop synergies with other functions / areas o Ability to take initiatives, strong analytical and problem-solving skills o Proficient with MS Office (Excel, Word and Power Point)  Language skills:o Language Fluent or proficient in both French and English languages You would like to contribute to a fast-thinking and innovative company, changing the industry ? Apply nowPlease note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position 
    Do you wish to be part of a high-growth, transformational company that is Bold, Innovative, Curious, and Collaborative ?For our client, a pioneering life science company, we are looking for a: Quality Assurance ManagerLocation: GenevaPermanent position You will report directly to the Chief Operating Officer. In this role, you are in charge of coordinating and supporting the implementation of the Quality Management System, ensuring compliance with industry best practices and applicable standards and in developing the company quality culture by providing guidance to management and employees on quality-related questions.  Your Responsibilities:   Key Quality representative o Actively contribute to the development and continuous improvement of Quality Management System o Act as key contact point for quality topics within the organization, providing guidance to laboratories and support functionso Promote quality culture across the organisation o Report Key Quality Indicators to management  Documentation management system o Coordinate the implementation and maintenance of documentation system (including procedures, SOPs, forms and templates) o Ensure documents are handled in accordance with applicable standards, Good Documentation Practices and procedures o Support laboratory staff and support functions in the implementation, monitoring and improvement of quality processes Quality processes Develop, implement and maintain quality processes (e.g. documentation control, handling of incidents, change management) o Contribute to the development and implementation of other processes, providing guidance to teams (e.g. process definition, creation of related documentation) o Review and assess quality-relevant information (e.g. as part of incident management, change management or Vendor qualification processes), as appropriate o Provide training to employees on quality processes and procedures Auditso Perform regular quality audits (“spot checks”) to monitor compliance to internal procedures and applicable standards. o Act as quality representative during customer audits – collect information and prepare answers to qualification and audit questionnaires, accompany customers during on-site audits. Your profile: Education / Experience o University degree in Biology/Biochemistry/Chemistry or Pharmacy o 4-8 years of experience in Quality Assurance in pharmaceutical, biotechnology or health sciences industry o Practical experience of quality management systems – experience in research and development field is an asset o Good knowledge of pharmaceutical guidelines, standards and best practices  Skills / Knowledge o Good communication skills - including writing, speaking and training/teaching skills o Proven organizational skills, ability to handle multiple priorities o Ability to work independently as well as in a team environment o Ability to collaborate and develop synergies with other functions / areas o Ability to take initiatives, strong analytical and problem-solving skills o Proficient with MS Office (Excel, Word and Power Point)  Language skills:o Language Fluent or proficient in both French and English languages You would like to contribute to a fast-thinking and innovative company, changing the industry ? Apply nowPlease note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position 
    • luterbach, solothurn
    • contract
    Do you want to work in a biotech company? Do you have at least 4 years experience in QA? You should then read the following lines! Our client, based in Solothurn, is looking for a Quality Assurance Operations Associate III for a 8 months contract. The Quality Assurance Operations Associate assures that all operations meet or exceed cGMP regulations ensuring the quality Bulk Drug Substance, cell bank supporting on shop floor the daily manufacturing and facility operations. The position needs reactive support of discrepancy identification, resolution on the floor, root cause analysis and corrective action for product and process related non-conformances. The holder will collaborate with product Quality Management for change control. This is accomplished by direct collaboration and oversight of Manufacturing Operations and the review/audit of data and reports as specified by Standard Operating Procedures. This position will support quality key metrics and analysis.As such, the position is expected to have knowledge in cell culture, purifications process, operations and business processes within a GMP Biotech environment. Previous experience with manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be an advantage. As the facility is designed to be a high-throughput facility it will also be beneficial to have experience with LEAN, Six Sigma and continuous improvements.You work on the field, having an oversight over the manufacturing operations from a quality point of view and the electronic batch record review (QRM). You will review and approve Standard Operating Procedures (SOP) and you will perform ad hoc sampling and testing. You report to the Quality Assurance Operations Supervisor and work cross-functional with different quality units (QC, Product Quality, Corporate Quality, QA). You work in a 5-shift model along side the manufacturing team, within this you will work with other Quality Assurance Operations Associate colleagues and your Supervisor. QUALIFICATIONS:Previous experience in quality assurance and/or operation experience in pharmaceutical or biotech manufacturing environment. Prior experience with fully electronic operations and management is preferred.Good experience of process design and improvement.Strong working experience with GxP regulationsElectronic Batch Record and elogbook management will be an asset KNOWLEDGE AND SKILLS:Good oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectivelyDemonstrated ability to work autonomously and lead projectCandidates with experience in drug substance (or API) and drug product are preferred.Demonstrated problem solving skillsProficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems.Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)Ability to work in shift model (night as well) including during the weekend Do not waste any minutes, apply now!  We are looking forward to receiving your application. 
    Do you want to work in a biotech company? Do you have at least 4 years experience in QA? You should then read the following lines! Our client, based in Solothurn, is looking for a Quality Assurance Operations Associate III for a 8 months contract. The Quality Assurance Operations Associate assures that all operations meet or exceed cGMP regulations ensuring the quality Bulk Drug Substance, cell bank supporting on shop floor the daily manufacturing and facility operations. The position needs reactive support of discrepancy identification, resolution on the floor, root cause analysis and corrective action for product and process related non-conformances. The holder will collaborate with product Quality Management for change control. This is accomplished by direct collaboration and oversight of Manufacturing Operations and the review/audit of data and reports as specified by Standard Operating Procedures. This position will support quality key metrics and analysis.As such, the position is expected to have knowledge in cell culture, purifications process, operations and business processes within a GMP Biotech environment. Previous experience with manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be an advantage. As the facility is designed to be a high-throughput facility it will also be beneficial to have experience with LEAN, Six Sigma and continuous improvements.You work on the field, having an oversight over the manufacturing operations from a quality point of view and the electronic batch record review (QRM). You will review and approve Standard Operating Procedures (SOP) and you will perform ad hoc sampling and testing. You report to the Quality Assurance Operations Supervisor and work cross-functional with different quality units (QC, Product Quality, Corporate Quality, QA). You work in a 5-shift model along side the manufacturing team, within this you will work with other Quality Assurance Operations Associate colleagues and your Supervisor. QUALIFICATIONS:Previous experience in quality assurance and/or operation experience in pharmaceutical or biotech manufacturing environment. Prior experience with fully electronic operations and management is preferred.Good experience of process design and improvement.Strong working experience with GxP regulationsElectronic Batch Record and elogbook management will be an asset KNOWLEDGE AND SKILLS:Good oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectivelyDemonstrated ability to work autonomously and lead projectCandidates with experience in drug substance (or API) and drug product are preferred.Demonstrated problem solving skillsProficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems.Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)Ability to work in shift model (night as well) including during the weekend Do not waste any minutes, apply now!  We are looking forward to receiving your application. 
    • basel, basel-stadt
    • contract
    Randstad Professionals is looking for an Associate Director, Signal Management for a major client. This position will be based in Basel .Startdate: ASAP (up to 3 month notice period possible)Contract: 12 monthsThis position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally. Your responsibilities:Provide dynamic strategic contribution to the direction and senior leaders of key pharmacovigilance activities across portfolio and throughout the clinical development and post-marketing phases of the life cycle including: Lead all signal management activities for assigned product(s)  Support implantation of signal detection strategy approved by VP of Pharmacovigilance  Review adverse event data, literature and other safety-related data for the purpose of signal detection  Collaborate with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues to review safety data for signal validation, prioritization, assessment and proposed action plans Partner with the Director, Pharmacovigilance – Signal Management to oversee digital signal detection and management tool.  Serve as an administrator of the tool  Propose and implement signal detection methods in the tool  Train, mentor and assist CSRM staff in using the tool.  Oversee signal tracking and signal notifications to external stakeholders  Generate periodic signal management compliance metrics Provide safety contents for risk management plans and periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, and IND annual reports in collaboration with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues  Reviews applicable regulatory intelligence on global regulations/guidance documents and be able to advise report project teams as a Subject Matter Expert (SME) for signal management.  Understand relationships and dependencies between signal management and documents/analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other annual reports and/or deliverables  Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission  Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents  Produce high quality, accurate, and fit-for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasons  Review the worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with CSRM colleagues  Draft regulatory response documents such as PRAC assessment reports  Draft other medical writing deliverables as needed If you are interested to take on these responsibilities you should have the following requirements:Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background  Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 5 years’ experience in Pharmacovigilance  Excellent written and verbal communication skills with the ability to interpret and present safety data  Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process  Knowledge of drug safety/pharmacovigilance practices and tools  Ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervision  Background in vaccines is a plus  Demonstrated ability to develop, execute and follow-through complex projects to completion  Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view  Independently motivated, detail oriented and strong problem-solving ability  Excellent organizational skills and demonstrated ability to multitask in a fast-paced environment with changing priorities  Excellent written and verbal communication skills with the ability to interact across multiple functions Did we spark your interest? We look forward to receiving your online application. Please note a Swiss Work permit is mandatory and your residence needs to be in Switzerland for this position. 
    Randstad Professionals is looking for an Associate Director, Signal Management for a major client. This position will be based in Basel .Startdate: ASAP (up to 3 month notice period possible)Contract: 12 monthsThis position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally. Your responsibilities:Provide dynamic strategic contribution to the direction and senior leaders of key pharmacovigilance activities across portfolio and throughout the clinical development and post-marketing phases of the life cycle including: Lead all signal management activities for assigned product(s)  Support implantation of signal detection strategy approved by VP of Pharmacovigilance  Review adverse event data, literature and other safety-related data for the purpose of signal detection  Collaborate with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues to review safety data for signal validation, prioritization, assessment and proposed action plans Partner with the Director, Pharmacovigilance – Signal Management to oversee digital signal detection and management tool.  Serve as an administrator of the tool  Propose and implement signal detection methods in the tool  Train, mentor and assist CSRM staff in using the tool.  Oversee signal tracking and signal notifications to external stakeholders  Generate periodic signal management compliance metrics Provide safety contents for risk management plans and periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, and IND annual reports in collaboration with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, and medical colleagues Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues  Reviews applicable regulatory intelligence on global regulations/guidance documents and be able to advise report project teams as a Subject Matter Expert (SME) for signal management.  Understand relationships and dependencies between signal management and documents/analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other annual reports and/or deliverables  Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission  Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents  Produce high quality, accurate, and fit-for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasons  Review the worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with CSRM colleagues  Draft regulatory response documents such as PRAC assessment reports  Draft other medical writing deliverables as needed If you are interested to take on these responsibilities you should have the following requirements:Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background  Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 5 years’ experience in Pharmacovigilance  Excellent written and verbal communication skills with the ability to interpret and present safety data  Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process  Knowledge of drug safety/pharmacovigilance practices and tools  Ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervision  Background in vaccines is a plus  Demonstrated ability to develop, execute and follow-through complex projects to completion  Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view  Independently motivated, detail oriented and strong problem-solving ability  Excellent organizational skills and demonstrated ability to multitask in a fast-paced environment with changing priorities  Excellent written and verbal communication skills with the ability to interact across multiple functions Did we spark your interest? We look forward to receiving your online application. Please note a Swiss Work permit is mandatory and your residence needs to be in Switzerland for this position. 
    • neuchâtel, neuchâtel
    • temporary
     Pour notre client international situé près de Neuchâtel et actif dans les équipements médicaux, nous recherchons un(e) inspecteur(-trice) contrôle qualité. Il s’agit d’une mission intérimaire jusqu’à fin Juin 2022. Vos tâches:Vous réalisez la revue de la documentation (ex: vérification des dossiers de fabrication selon les exigences qualité de l’entreprise).Vous assurez l'archivage de la documentation (ex: dossiers de fabrication).Vous procédez à la libération finale des lots d'équipements médicaux issus de la production selon les règles établies de l' entreprise.Vous effectuez les contrôles des produits à réception ou en cours de fabrication ainsi que des produits finaux avant la libération des lots.Vous assurez le support qualité en production.Vous assurez l'inspection des composants en cours de validation.Vous assurez la formation des nouveaux inspecteurs.Vous êtes en charge des méthodes de contrôle (ex: Micromètrie, Calibration, Mesure 3D optique).Vous avez une très bonne compréhension des dessins techniques.  Votre profil:Vous avez un CFC ou une formation équivalente de technicien(ne) de laboratoire en biologie, chimie ou physique.Vous avez 2 à 3 ans d’expériences dans le domaine du contrôle qualité avec de préférence une première expérience en équipements médicaux.Vous connaissez les normes ISO 9000/ISO 13485/FDA part 820.Vous êtes organisé(e), méthodique et autonome avec un esprit d'équipe et un bon sens de la communication.Vous avez une bonne connaissance de Microsoft Word et Excel.Vous parlez et écrivez le français.
     Pour notre client international situé près de Neuchâtel et actif dans les équipements médicaux, nous recherchons un(e) inspecteur(-trice) contrôle qualité. Il s’agit d’une mission intérimaire jusqu’à fin Juin 2022. Vos tâches:Vous réalisez la revue de la documentation (ex: vérification des dossiers de fabrication selon les exigences qualité de l’entreprise).Vous assurez l'archivage de la documentation (ex: dossiers de fabrication).Vous procédez à la libération finale des lots d'équipements médicaux issus de la production selon les règles établies de l' entreprise.Vous effectuez les contrôles des produits à réception ou en cours de fabrication ainsi que des produits finaux avant la libération des lots.Vous assurez le support qualité en production.Vous assurez l'inspection des composants en cours de validation.Vous assurez la formation des nouveaux inspecteurs.Vous êtes en charge des méthodes de contrôle (ex: Micromètrie, Calibration, Mesure 3D optique).Vous avez une très bonne compréhension des dessins techniques.  Votre profil:Vous avez un CFC ou une formation équivalente de technicien(ne) de laboratoire en biologie, chimie ou physique.Vous avez 2 à 3 ans d’expériences dans le domaine du contrôle qualité avec de préférence une première expérience en équipements médicaux.Vous connaissez les normes ISO 9000/ISO 13485/FDA part 820.Vous êtes organisé(e), méthodique et autonome avec un esprit d'équipe et un bon sens de la communication.Vous avez une bonne connaissance de Microsoft Word et Excel.Vous parlez et écrivez le français.
    • le locle, neuchâtel
    • temporary
    We are looking for a Quality Supplier Specialist to work for a mission of 1 year at our client specialized in the medical device. It is an international company near Neuchâtel.  Your mission: - You are responsible for Supplier Quality engineering functions for our swiss facility;- You participate in supplier assessments and continuous improvement activities at supplier facilities, MRB activities, and metrics activities;- You will also provide Quality Engineering support to the team;- You develop and implement Quality Systems procedures, as well as modifications to existing Inspection plans- You provide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. FDA CFR part 820, EU MDR, and ISO 13485 regulations/standards will be the focus;- You ensure that activities for validation of outsourced new processes/products are performed and documented according to applicable procedures. Your profile: - You have a Bachelor’s Degree in Engineering, Life Science, or a related technical discipline.- You are experienced in performing Root Cause analysis and Special Process Validations.- You are experienced in a Medical Device manufacturing environment.- You have a solid knowledge of the QSR and ISO9001 / EN46001 / ISO13485 quality requirements- You have statistical knowledge.- You speak very good French and English.
    We are looking for a Quality Supplier Specialist to work for a mission of 1 year at our client specialized in the medical device. It is an international company near Neuchâtel.  Your mission: - You are responsible for Supplier Quality engineering functions for our swiss facility;- You participate in supplier assessments and continuous improvement activities at supplier facilities, MRB activities, and metrics activities;- You will also provide Quality Engineering support to the team;- You develop and implement Quality Systems procedures, as well as modifications to existing Inspection plans- You provide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. FDA CFR part 820, EU MDR, and ISO 13485 regulations/standards will be the focus;- You ensure that activities for validation of outsourced new processes/products are performed and documented according to applicable procedures. Your profile: - You have a Bachelor’s Degree in Engineering, Life Science, or a related technical discipline.- You are experienced in performing Root Cause analysis and Special Process Validations.- You are experienced in a Medical Device manufacturing environment.- You have a solid knowledge of the QSR and ISO9001 / EN46001 / ISO13485 quality requirements- You have statistical knowledge.- You speak very good French and English.
    • luterbach, solothurn
    • contract
    Do you want to work in a biotech company? Do you have a first experience in a GMP environment? You should then read the following lines! Our client, based in Solothurn, is looking for a Manufacturing Associate for a 1 year-mission. JOB SUMMARY:Performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The manufacturing associate is detail-oriented with strong understanding of automated systems and process controls. Individual will maintain training to the required level and support other functions on site.Executes manufacturing processing steps and/or manufacturing support activities using electronic batch records RESPONSIBILITIES:- Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the recipe & MFG documentation- Actively participates in training activities, managing their individual training plan. Trains other associates as required.- Executes validation protocols- And other job duties that may be assigned from time to time. REQUIREMENTS:• High school diploma or equivalent experience and typically 3-5 years relevant experience in related or non-related industry or 2-3 years experience in Pharma/Biotech industryOR• Bachelor degree in related filed with 1-2 years professional experienceOR• Bachelor degree in not related field and typically 3-4 years experience• Languages: English B1, German and/or French an assetShift work is required for this position Do not waste any minutes, apply now! We are looking forward to receiving your application.
    Do you want to work in a biotech company? Do you have a first experience in a GMP environment? You should then read the following lines! Our client, based in Solothurn, is looking for a Manufacturing Associate for a 1 year-mission. JOB SUMMARY:Performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The manufacturing associate is detail-oriented with strong understanding of automated systems and process controls. Individual will maintain training to the required level and support other functions on site.Executes manufacturing processing steps and/or manufacturing support activities using electronic batch records RESPONSIBILITIES:- Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the recipe & MFG documentation- Actively participates in training activities, managing their individual training plan. Trains other associates as required.- Executes validation protocols- And other job duties that may be assigned from time to time. REQUIREMENTS:• High school diploma or equivalent experience and typically 3-5 years relevant experience in related or non-related industry or 2-3 years experience in Pharma/Biotech industryOR• Bachelor degree in related filed with 1-2 years professional experienceOR• Bachelor degree in not related field and typically 3-4 years experience• Languages: English B1, German and/or French an assetShift work is required for this position Do not waste any minutes, apply now! We are looking forward to receiving your application.
    • oberdorf, nidwalden
    • contract
    Do you want to work in a medical device company ? Do you have at least 4 years experience in Regulatory Affairs ? You should then read the following lines!Our client, based in Solothurn, is looking for a Regulatory Affairs Specialist for a mission until the end of the year with strong possibility for extension  OVERALL RESPONSIBILITIES:Support MDR compliance execution work for the Powertools business by creation/update of Technical Documentation of existing devices to comply with MDR requirements POSITION DUTIES & RESPONSIBILITIES:• Identify, create and/or update reference documents for technical documentation including, but not limited to design and risk documents, verification/validation documents, standards conformance, Clinical Evaluation Reports, General Safety and Performance (GSRP) Checklists, Table of Contents, Declaration of Conformity, and labeling.• Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches inclusive of site transfer activities.• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.• As required, coordinate with various Technical file cross functional teams to make sure that data is aligned across the spectrum.• Identify and adhere to policies, procedures and work instructions which support technical documentation activities• Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assist in review of international product technical documents, marketing and labeling materials• Align and create technical documentation according to OneMD technical documentation structure proposed by the MDR team and/ or according to updated procedures by fulfilling RA deliverables according to project plan• Support for routing and implementation of the remediated documents in PLM systems• Support preparation of technical or design dossier documentation for submission to and review by Notified Bodies, as required• Provide support for preparation activities for MDR compliance including, but not limited to data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned• Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations EXTENDED DUTIES:• Follow the quality standards and regulatory requirements• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times• Resolving complex issues as they arise PROFESSIONAL EXPERIENCE REQUIREMENTS:• At least 5 years of experience in European Medical device as regulatory affairs specialist• Strong knowledge of ISO 13485 and ISO 9001, QSR,• understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745)• MEDDEV guidance documents applicable to Medical Devices products and processes• Strong understanding of Risk Management process, label and labeling, change management is desired EDUCATIONAL REQUIREMENTS:• Master’s Degree in engineering or life sciences is required; LANGUAGE:• English fluent is mandatory (all documentation in English) OTHER REQUIREMENTS:• Strong knowledge and skills in MS Office• Familiarity with Technical Documentation structure according to STED required• Strong interpersonal and diplomatic skills• Team work oriented, within a multi-functional and multi-national team• Customer / service orientation• High analytical, planning and organizational skills; able to set priorities Do not waste any minutes, apply now!  We are looking forward to receiving your application. 
    Do you want to work in a medical device company ? Do you have at least 4 years experience in Regulatory Affairs ? You should then read the following lines!Our client, based in Solothurn, is looking for a Regulatory Affairs Specialist for a mission until the end of the year with strong possibility for extension  OVERALL RESPONSIBILITIES:Support MDR compliance execution work for the Powertools business by creation/update of Technical Documentation of existing devices to comply with MDR requirements POSITION DUTIES & RESPONSIBILITIES:• Identify, create and/or update reference documents for technical documentation including, but not limited to design and risk documents, verification/validation documents, standards conformance, Clinical Evaluation Reports, General Safety and Performance (GSRP) Checklists, Table of Contents, Declaration of Conformity, and labeling.• Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches inclusive of site transfer activities.• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.• As required, coordinate with various Technical file cross functional teams to make sure that data is aligned across the spectrum.• Identify and adhere to policies, procedures and work instructions which support technical documentation activities• Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assist in review of international product technical documents, marketing and labeling materials• Align and create technical documentation according to OneMD technical documentation structure proposed by the MDR team and/ or according to updated procedures by fulfilling RA deliverables according to project plan• Support for routing and implementation of the remediated documents in PLM systems• Support preparation of technical or design dossier documentation for submission to and review by Notified Bodies, as required• Provide support for preparation activities for MDR compliance including, but not limited to data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned• Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations EXTENDED DUTIES:• Follow the quality standards and regulatory requirements• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times• Resolving complex issues as they arise PROFESSIONAL EXPERIENCE REQUIREMENTS:• At least 5 years of experience in European Medical device as regulatory affairs specialist• Strong knowledge of ISO 13485 and ISO 9001, QSR,• understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745)• MEDDEV guidance documents applicable to Medical Devices products and processes• Strong understanding of Risk Management process, label and labeling, change management is desired EDUCATIONAL REQUIREMENTS:• Master’s Degree in engineering or life sciences is required; LANGUAGE:• English fluent is mandatory (all documentation in English) OTHER REQUIREMENTS:• Strong knowledge and skills in MS Office• Familiarity with Technical Documentation structure according to STED required• Strong interpersonal and diplomatic skills• Team work oriented, within a multi-functional and multi-national team• Customer / service orientation• High analytical, planning and organizational skills; able to set priorities Do not waste any minutes, apply now!  We are looking forward to receiving your application. 
    • basel, basel-stadt
    • temporary
    For our client, a growing company in the pharmaceutical industry, we are looking for a :Planning Coordinator/Expert Location: BaselContract: Temporary for 6 months with possibility to extend or become permanentMain objective:This position is responsible to manage the operational planning incl. inbound flows (orders and shipments) and the associated tools/processes (incl. Artwork management). Acts as Super User in the management of the SAP setup (MM, IBP)Your Main Responsibilities:  Perform monthly supply planning operations in close cooperation with the Global Planning Manager (in Excel and SAP IBP)Supply PO placement with suppliers and follow upManagement of inbound flows incl. organization of inbound shipments from supplier to HUBSuper User SAP (MM,IBP) supporting the SAP implementations and ensuring correct setup of SAP in collaboration with the business and ITMaintain SAP Master Data accuracyManage/support projects in the Supply Chain areaEnsure operationally with external Artwork Supplier and internal functions management of Artwork changesYour profile:University Degree in Supply Chain or very Supply Chain related functionsMin 3 years on hand experience as Planning Coordinator/Expert with intense exposure to SAP and Artwork creation, preferably in the pharmaceutical/Consumer Health businessVery strong analytical thinkingSelf-starter, able to work independently and picking up responsibility in a newly created Supply chainContinuous Improvement mindset.Ability to work accurately under pressureAbility to work in remote teamsSAP (IBP, MM)MS Excel (very good knowledge incl. creation of own complex reports/spreadsheets)Very good English (must have),French & Italian (asset) Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position 
    For our client, a growing company in the pharmaceutical industry, we are looking for a :Planning Coordinator/Expert Location: BaselContract: Temporary for 6 months with possibility to extend or become permanentMain objective:This position is responsible to manage the operational planning incl. inbound flows (orders and shipments) and the associated tools/processes (incl. Artwork management). Acts as Super User in the management of the SAP setup (MM, IBP)Your Main Responsibilities:  Perform monthly supply planning operations in close cooperation with the Global Planning Manager (in Excel and SAP IBP)Supply PO placement with suppliers and follow upManagement of inbound flows incl. organization of inbound shipments from supplier to HUBSuper User SAP (MM,IBP) supporting the SAP implementations and ensuring correct setup of SAP in collaboration with the business and ITMaintain SAP Master Data accuracyManage/support projects in the Supply Chain areaEnsure operationally with external Artwork Supplier and internal functions management of Artwork changesYour profile:University Degree in Supply Chain or very Supply Chain related functionsMin 3 years on hand experience as Planning Coordinator/Expert with intense exposure to SAP and Artwork creation, preferably in the pharmaceutical/Consumer Health businessVery strong analytical thinkingSelf-starter, able to work independently and picking up responsibility in a newly created Supply chainContinuous Improvement mindset.Ability to work accurately under pressureAbility to work in remote teamsSAP (IBP, MM)MS Excel (very good knowledge incl. creation of own complex reports/spreadsheets)Very good English (must have),French & Italian (asset) Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position 
    • stein, aargau
    • contract
    For our client, a pharmaceutical company in the Basel area we are looking for aLab Head/Lab Coordinator (QA)Start date: latest June 2021End date: 31.05.2022, with the possibility of extensionTasks & Responsibilities:GMP-konforme Beurteilung und Entscheid von unkritischen und kritischen DeviationsUnterstützung bei internen und externen Audits und SelbstinspektionenBereitstellung von Daten & Informationen für QA/CPL (z.B. für APR/PQRs, Quartalsberichte, etc)Erstellen und Aktualisierung von SOPsÜberprüft oder genehmigt produktbezogene, qualitätsrelevante Dokumente wie z.B. Validierungsberichte, APR/PQR, Transferdokumente, etc.Must haves:Hochschulabschluss in Chemie/Pharmazie/Biologie/Medizin, gute GMP-Kenntnisse, EDV-Kenntnisse (MS Office Paket; SAP), Kenntnisse der Abläufe innerhalb Novartis Pharma wünschenswert (Galenik/Verpackung/QC).Deutsch und Englisch in Wort und SchriftMehrjähringe Erfahrung in der pharmazeutischer Qualitätskontrolle, Qualitätssicherung oder pharmazeutischer Produktion
    For our client, a pharmaceutical company in the Basel area we are looking for aLab Head/Lab Coordinator (QA)Start date: latest June 2021End date: 31.05.2022, with the possibility of extensionTasks & Responsibilities:GMP-konforme Beurteilung und Entscheid von unkritischen und kritischen DeviationsUnterstützung bei internen und externen Audits und SelbstinspektionenBereitstellung von Daten & Informationen für QA/CPL (z.B. für APR/PQRs, Quartalsberichte, etc)Erstellen und Aktualisierung von SOPsÜberprüft oder genehmigt produktbezogene, qualitätsrelevante Dokumente wie z.B. Validierungsberichte, APR/PQR, Transferdokumente, etc.Must haves:Hochschulabschluss in Chemie/Pharmazie/Biologie/Medizin, gute GMP-Kenntnisse, EDV-Kenntnisse (MS Office Paket; SAP), Kenntnisse der Abläufe innerhalb Novartis Pharma wünschenswert (Galenik/Verpackung/QC).Deutsch und Englisch in Wort und SchriftMehrjähringe Erfahrung in der pharmazeutischer Qualitätskontrolle, Qualitätssicherung oder pharmazeutischer Produktion

It looks like you want to switch your language. This will reset your filters on your current job search.