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1 job found in Vaud

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    • lausanne, vaud
    • temporary
    Do you have several years of experience in quality in the medical industry ? Do you like to take part in multi team projects ? You should then read the following description!For one of our clients, we are looking for a Global Product Development Quality Lead, for their site in the Lausanne area. The mission is to last from 01.03.2022 until the end of Jan 2023. Tasks:Lead the Quality Management System (QMS) for Combination Products (CP) across different departments.Ensure quality of product development through Good Manufacturing Practices (GMP) or relevant requirements.Secure compliant product availability to patients and consumers for (pre-)clinical/claim studies.Reviewing/approving quality deliverables related to products in development within manufacturing facilities as well as CDMOsProviding quality expertise on GDP/GMP/ISO requirements during product early and late clinical phasesQuality representative in product development projectsProviding support for product transfers to commercial phaseEnsuring qualification of vendors used in development project Organizing/performing quality audits for products in developmentResponsible for QMS elements like IP complaints, deviations and CAPAsRegular meetings and collaboration with main stakeholders (CMC Project Managers, Regulatory, Clinical Supply Representatives, Clinical Project Managers and commercial QA)Quality Representative in MD division including following duties/responsibilities:responsible for Quality Control and Quality Assurance activities used to ensure processes are sufficient to detect and control nonconformities encountered during design and manufacturing maintaining Quality Manual, QMS policies, procedures, and work instructions for MDs and Combination Productssupervising operational quality activities (Change Controls, Nonconformities, Development Reviews….) for MD and Combination ProductsProfile:University degree in Science including Chemistry, Biology, Pharmacy, Engineering.Advanced courses on GMP/GDPExperience in the pharmaceutical/biotech/medical devices industrySolid background in QualityProject management skillsRegulatory inspection experience Those lines sound familiar and appealing to you ? Apply now!
    Do you have several years of experience in quality in the medical industry ? Do you like to take part in multi team projects ? You should then read the following description!For one of our clients, we are looking for a Global Product Development Quality Lead, for their site in the Lausanne area. The mission is to last from 01.03.2022 until the end of Jan 2023. Tasks:Lead the Quality Management System (QMS) for Combination Products (CP) across different departments.Ensure quality of product development through Good Manufacturing Practices (GMP) or relevant requirements.Secure compliant product availability to patients and consumers for (pre-)clinical/claim studies.Reviewing/approving quality deliverables related to products in development within manufacturing facilities as well as CDMOsProviding quality expertise on GDP/GMP/ISO requirements during product early and late clinical phasesQuality representative in product development projectsProviding support for product transfers to commercial phaseEnsuring qualification of vendors used in development project Organizing/performing quality audits for products in developmentResponsible for QMS elements like IP complaints, deviations and CAPAsRegular meetings and collaboration with main stakeholders (CMC Project Managers, Regulatory, Clinical Supply Representatives, Clinical Project Managers and commercial QA)Quality Representative in MD division including following duties/responsibilities:responsible for Quality Control and Quality Assurance activities used to ensure processes are sufficient to detect and control nonconformities encountered during design and manufacturing maintaining Quality Manual, QMS policies, procedures, and work instructions for MDs and Combination Productssupervising operational quality activities (Change Controls, Nonconformities, Development Reviews….) for MD and Combination ProductsProfile:University degree in Science including Chemistry, Biology, Pharmacy, Engineering.Advanced courses on GMP/GDPExperience in the pharmaceutical/biotech/medical devices industrySolid background in QualityProject management skillsRegulatory inspection experience Those lines sound familiar and appealing to you ? Apply now!

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