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.
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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.
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Titre du poste : Technicien Expert QADépartement : Opérations Techniques / FabricationLocalisation : Nord Vaudois Poste temporaire jusqu'à la fin de l'année En tant que Spécialiste Senior Conformité, vous êtes le garant de la culture qualité au cœur même de nos ateliers de production. Votre mission est de piloter l’ensemble des sujets liés à la conformité (déviations, CAPA, gestion des risques, contrôles de changements) tout en soutenant nos objectifs de p
Titre du poste : Technicien Expert QADépartement : Opérations Techniques / FabricationLocalisation : Nord Vaudois Poste temporaire jusqu'à la fin de l'année En tant que Spécialiste Senior Conformité, vous êtes le garant de la culture qualité au cœur même de nos ateliers de production. Votre mission est de piloter l’ensemble des sujets liés à la conformité (déviations, CAPA, gestion des risques, contrôles de changements) tout en soutenant nos objectifs de p
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