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.