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8 jobs found for biotechnology pharmaceutical

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    • basel, basel-stadt
    • contract
    Do you want to work in a big pharmaceutical company? Do you have experience in regulatory submissions? You should then read the following lines! Our client, based in Basel, is looking for a Global Program Regulatory Manager (GPRM) for an 8 months contract.  Your Tasks:Regulatory Strategy1. Responsible for implementing regulatory strategy and managing operational activities for assigned regions.2. Partners with regions and the GPRD to align on regulatory strategy in order to fulfill business objectives.3. Represents RA on or leads sub-teams as required. HA Interactions1. Facilitates preparation and finalization of briefing books, and supports HA meetings / meeting preparation under the direction of the GPRD.2. Develops and implements plans for timely response to HA requests and coordinates responses.3. May serve as local HA (EMA) liaison. Submissions and Approvals1. Responsible for integrating global strategy into regional submissions worldwide.2. Coordinates, plans, and prepares for submission of dossiers in assigned regions worldwide.4. Review of global dossier summary documents. Responsible for preparation, review, finalization of regulatory documents for submission.7. Participates in negotiations for approvals as required.8. Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the GPRD. Prescribing Information1. Assists with generating local PIs and ensuring that they are integrated with the CDS.2. Revise labels as needed to achieve timely HA approval with best possible label based on available data.3. 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. Ensures regulatory compliance for assigned project 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. Your Profile:Education (Minimum/desirable): Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. · Experience with regulatory submission and approval processes in 1 or more major regions (minimum EU Centralized Procedure).· Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry.· Experience in HA negotiations.· 2-4 years involvement in regulatory and drug/biologic development.· Strong interpersonal, communication, negotiation and problem solving skills. 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 regulatory submissions? You should then read the following lines! Our client, based in Basel, is looking for a Global Program Regulatory Manager (GPRM) for an 8 months contract.  Your Tasks:Regulatory Strategy1. Responsible for implementing regulatory strategy and managing operational activities for assigned regions.2. Partners with regions and the GPRD to align on regulatory strategy in order to fulfill business objectives.3. Represents RA on or leads sub-teams as required. HA Interactions1. Facilitates preparation and finalization of briefing books, and supports HA meetings / meeting preparation under the direction of the GPRD.2. Develops and implements plans for timely response to HA requests and coordinates responses.3. May serve as local HA (EMA) liaison. Submissions and Approvals1. Responsible for integrating global strategy into regional submissions worldwide.2. Coordinates, plans, and prepares for submission of dossiers in assigned regions worldwide.4. Review of global dossier summary documents. Responsible for preparation, review, finalization of regulatory documents for submission.7. Participates in negotiations for approvals as required.8. Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the GPRD. Prescribing Information1. Assists with generating local PIs and ensuring that they are integrated with the CDS.2. Revise labels as needed to achieve timely HA approval with best possible label based on available data.3. 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. Ensures regulatory compliance for assigned project 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. Your Profile:Education (Minimum/desirable): Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. · Experience with regulatory submission and approval processes in 1 or more major regions (minimum EU Centralized Procedure).· Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry.· Experience in HA negotiations.· 2-4 years involvement in regulatory and drug/biologic development.· Strong interpersonal, communication, negotiation and problem solving skills. 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. 
    • oberdorf, nidwalden
    • contract
    Do you want to work in a big medical devices company? Do you have at least 2 years experience in RA for Medical Devices? You should then read the following lines! Our client, based in the Solothurn area, is looking for a CH - Specialist 3, Regulatory Affairs for a 1 year contract. Your Tasks: • 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• 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 Your Profile:• Master’s Degree in engineering or life sciences is required;• 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• English fluent is mandatory (all documentation in English) 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 at least 2 years experience in RA for Medical Devices? You should then read the following lines! Our client, based in the Solothurn area, is looking for a CH - Specialist 3, Regulatory Affairs for a 1 year contract. Your Tasks: • 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• 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 Your Profile:• Master’s Degree in engineering or life sciences is required;• 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• English fluent is mandatory (all documentation in English) 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.
    • basel, basel-stadt
    • contract
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    • basel, basel-stadt
    • contract
    For our client, an international biotech company, we are looking for a: Procurement Buyer Location:BaselContract: Temporary for 6 month to 1 year We are looking for a customer service-oriented Buyer who has experience with ERP systems and Procurement processes.  The successful candidate will have experience in the Biotech/Pharma industry with a solid understanding of Procurement/Supply Chain Management concepts. For collaboration purposes, we require strong communication and cultural sensitivity with colleagues in the US, Europe, and Asia.  As a valuable resource to the organization, the incumbent is pro-active and brings strong analytical and problem-solving skills with the ability to work in a non-structured environment Your Responsibilities: Contribute to internal training and provide support to requisitioners on vendor creation, updates, purchase requisitions, and other procurement processesReview purchase requisitions for completeness and compliance with the Procurement policy.Review support documentation, currency, payment terms, alignment of back up documentation, and clarity of description Liaise with the business teams as applicable to follow up on purchase requisitions failing to meet required standards with a view to the efficient resolution of issuesWork with requisitioners to ensure change orders and other updates to POs are complete, accurate, and efficientGenerate Purchase Orders (POs) for communication to vendorsMaintain all appropriate backup documentation in association with each PO as requiredAssist with analyzing proposals/quotations for services, supplies, and equipmentParticipate in the annual review of vendor information, e.g., payment terms, material groups, vendor activityProduce and develop required reports regularly to track and monitor various areas of performance, such as perfunctory POs, PO usage, and Requisition conversionEnsure compliance to all company and Procure to Pay specific policies relevant to the performance of the role, maintain records as specified, and support and participate in internal and external process audits as requiredResolve inquiries and professionally escalate concerns as neededProfessionally communicate order discrepancies and take corrective actionParticipate in business reviews with vendors and staffPerform other related duties as assigned by managerDue to the global nature of the company, a flexible approach to working hours is necessaryProficient in writing work processes and contributing to SOP’s.Performing UAT when necessary Your profile:Demonstrated capabilities with ERP systems required (SAP preferred) as well as strong personal computing skills, including proficiency with Microsoft Outlook, Excel, Word.  Facility with and passion for working with systems and data a plus.BA or BS degree, or equivalent related experience3-5 years of experience in Procurement/Sourcing is requiredBiotech/Pharma industry experienceExcellent spoken and written English and GermanStrong customer service orientation and a sense of urgency are requiredExcellent oral and written communication skillsGood critical thinking skillsDetail-orientedAbility to resolve customer issuesWell organized, able to manage competing prioritiesAdaptability, flexibility, resilience, and independent working skillsContinuous improvement approachTeam player Please note Swiss work permit or EU citizenship is required for this position
    For our client, an international biotech company, we are looking for a: Procurement Buyer Location:BaselContract: Temporary for 6 month to 1 year We are looking for a customer service-oriented Buyer who has experience with ERP systems and Procurement processes.  The successful candidate will have experience in the Biotech/Pharma industry with a solid understanding of Procurement/Supply Chain Management concepts. For collaboration purposes, we require strong communication and cultural sensitivity with colleagues in the US, Europe, and Asia.  As a valuable resource to the organization, the incumbent is pro-active and brings strong analytical and problem-solving skills with the ability to work in a non-structured environment Your Responsibilities: Contribute to internal training and provide support to requisitioners on vendor creation, updates, purchase requisitions, and other procurement processesReview purchase requisitions for completeness and compliance with the Procurement policy.Review support documentation, currency, payment terms, alignment of back up documentation, and clarity of description Liaise with the business teams as applicable to follow up on purchase requisitions failing to meet required standards with a view to the efficient resolution of issuesWork with requisitioners to ensure change orders and other updates to POs are complete, accurate, and efficientGenerate Purchase Orders (POs) for communication to vendorsMaintain all appropriate backup documentation in association with each PO as requiredAssist with analyzing proposals/quotations for services, supplies, and equipmentParticipate in the annual review of vendor information, e.g., payment terms, material groups, vendor activityProduce and develop required reports regularly to track and monitor various areas of performance, such as perfunctory POs, PO usage, and Requisition conversionEnsure compliance to all company and Procure to Pay specific policies relevant to the performance of the role, maintain records as specified, and support and participate in internal and external process audits as requiredResolve inquiries and professionally escalate concerns as neededProfessionally communicate order discrepancies and take corrective actionParticipate in business reviews with vendors and staffPerform other related duties as assigned by managerDue to the global nature of the company, a flexible approach to working hours is necessaryProficient in writing work processes and contributing to SOP’s.Performing UAT when necessary Your profile:Demonstrated capabilities with ERP systems required (SAP preferred) as well as strong personal computing skills, including proficiency with Microsoft Outlook, Excel, Word.  Facility with and passion for working with systems and data a plus.BA or BS degree, or equivalent related experience3-5 years of experience in Procurement/Sourcing is requiredBiotech/Pharma industry experienceExcellent spoken and written English and GermanStrong customer service orientation and a sense of urgency are requiredExcellent oral and written communication skillsGood critical thinking skillsDetail-orientedAbility to resolve customer issuesWell organized, able to manage competing prioritiesAdaptability, flexibility, resilience, and independent working skillsContinuous improvement approachTeam player Please note Swiss work permit or EU citizenship is required for this position
    • 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.
    • 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. 
    • 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
    • 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.

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