Qa/qc expert

JobdescriptionJoin 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.ResponsibilitiesBatch 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.ProfileEducation: 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.