QA/QC Expert
RandstadYverdon les bainsJoin a fast-growing Bioplant in Yverdon-les-Bains during a pivotal expansion phase.We are seeking a QA QC Expert to ensure the highest quality standards for our Drug Substances and Raw Materials.Ba... Voir plus
Secrétariat médical Offres d'emploi - Yverdon-les-Bains, VD
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Secrétariat médical • yverdon les bains vd
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Senior Specialist Regulatory Affairs
Elos MedtechNord vaudois, CHSenior Specialist Regulatory Affairs (a).Elos Medtech is one of the world’s leading development and manufacturing partners for companies in the medical technology sector.With sites in Switzerland, ... Voir plus
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QA/QC Expert
Randstad (Schweiz) AGYverdon les bains, VaudJoin a fast-growing Bioplant in Yverdon-les-Bains during a pivotal expansion phase.We are seeking a QA QC Expert to ensure the highest quality standards for our Drug Substances and Raw Materials.Ba... Voir plus
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QA/QC Expert
RandstadYverdon les bainsIl y a plus de 30 jours
Description de poste
Jobdescription
Join a fast-growing Bioplant in Yverdon-les-Bains during a pivotal expansion phase. We are seeking a QA QC Expert to ensure the highest quality standards for our Drug Substances and Raw Materials.
Responsibilities
Profile
Profiles from Medical Devices or Solid Dosage will not be considered.
Join a fast-growing Bioplant in Yverdon-les-Bains during a pivotal expansion phase. We are seeking a QA QC Expert to ensure the highest quality standards for our Drug Substances and Raw Materials.
Responsibilities
- Batch Disposition: Collect and review all records for Drug Substance (DS) and Drug Product (DP) release; chair weekly disposition meetings.
- QA Oversight of QC: Provide day-to-day quality guidance to the lab, approving specifications, analytical methods, and sampling plans.
- Operational Quality: Lead QA activities for method transfers/validations and support the commissioning of new lab equipment.
- Quality Events: Manage Deviations, OOS (Out of Specification), OOT (Out of Trend), and Change Controls.
- Project Support: Contribute to the implementation of raw material testing and new sterility tests.
- Systems: Review LIMS master data changes and support computerized system integration.
Profile
- Education: Academic degree in Biotechnology, Pharmacy, Bioprocessing, or a related field.
- Experience: Minimum 5 years in a GMP environment.
- Industry Expertise (Mandatory): Solid experience in Biotech or Vaccines (Antibodies/Proteins).
- Technical Hybrid: Strong background in Quality Control (hands-on or oversight) transitioned into QA.
- Methods: Demonstrated experience in analytical method validation and transfer.
- Systems (Plus): Experience with LIMS (configuration or data review) is a significant advantage.
- Soft Skills: Pragmatic decision-maker, team player, and excellent communicator.
- Languages: Fluency in English and French is required.
Profiles from Medical Devices or Solid Dosage will not be considered.