Job Description
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
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. <...