4 jobs found in Solothurn, Solothurn

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    • 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. 
    • solothurn, solothurn
    • permanent
    Do you have a strong quality background in a manufacturing environment ? Do you want to develop your career in a renowned life science company ? You should then read the following lines!One of our clients, based in the Solothurn area, is looking for a Senior Quality Engineer for a permanent position. Tasks:You provide support to manufacturing areas within the facility for upcoming deviations and CAPAs related to equipment and automation of the production process and applying regulatory and compliance knowledge from multiple markets/agencies.You review and approve complex GMP documentation (Changes, plans, protocols, technical documentation, etc.) related to modifications of existing equipment and automation and may participate on projects requiring a high knowledge level of regulatory, Quality and Process systems.In addition, you support ongoing production and maintenance processes reviewing and approving related work orders in the electronic maintenance management system (EMMS).You work with the senior Quality Engineering Team to identify/revise/develop and implement complex Quality systems that can be global in scopeYou ensure adherence to internal procedures for facility/equipment controls and release before, during and after production operations (i.e. routine operations, shutdowns, construction projects, product changeover, etc.)You interact with regulatory agencies directly during audits as well as providing input into such documents as regulatory filings (may be expected to act as primary author for sections of filings)Profile:You have a bachelor’s Degree in a relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems, Computer ScienceYou bring a broad level of experience in a pharmaceutical or biotech manufacturing environment. With at least a solid previous experience within Quality Assurance, Validation or another related function. Automation/MES or related functions are preferred.You have and maintain knowledge of relevant FDA/EMA regulations and compliance.You have experience in validation of production equipment or cleaning utilities, automation systems and knowledge of production methodology involved in bio-pharmaceutical production.You have the ability to work in cross-functional teams Do those lines sound familiar to you ? Do not waste any second and apply now!
    Do you have a strong quality background in a manufacturing environment ? Do you want to develop your career in a renowned life science company ? You should then read the following lines!One of our clients, based in the Solothurn area, is looking for a Senior Quality Engineer for a permanent position. Tasks:You provide support to manufacturing areas within the facility for upcoming deviations and CAPAs related to equipment and automation of the production process and applying regulatory and compliance knowledge from multiple markets/agencies.You review and approve complex GMP documentation (Changes, plans, protocols, technical documentation, etc.) related to modifications of existing equipment and automation and may participate on projects requiring a high knowledge level of regulatory, Quality and Process systems.In addition, you support ongoing production and maintenance processes reviewing and approving related work orders in the electronic maintenance management system (EMMS).You work with the senior Quality Engineering Team to identify/revise/develop and implement complex Quality systems that can be global in scopeYou ensure adherence to internal procedures for facility/equipment controls and release before, during and after production operations (i.e. routine operations, shutdowns, construction projects, product changeover, etc.)You interact with regulatory agencies directly during audits as well as providing input into such documents as regulatory filings (may be expected to act as primary author for sections of filings)Profile:You have a bachelor’s Degree in a relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems, Computer ScienceYou bring a broad level of experience in a pharmaceutical or biotech manufacturing environment. With at least a solid previous experience within Quality Assurance, Validation or another related function. Automation/MES or related functions are preferred.You have and maintain knowledge of relevant FDA/EMA regulations and compliance.You have experience in validation of production equipment or cleaning utilities, automation systems and knowledge of production methodology involved in bio-pharmaceutical production.You have the ability to work in cross-functional teams Do those lines sound familiar to you ? Do not waste any second and apply now!
    • 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. 
    • 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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