QA/QC Expert

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

• 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.