Biologics Quality Assurance Specialist

vor 3 Wochen


Visp, Schweiz Lonza Vollzeit

About the Role:

This exciting new role at BioAtrium was created to increase real-time oversight and support for operations colleagues. BioAtrium is a growing organization with new projects being introduced, operating in a state-of-the-art Biologics Drug Substance facility.

Key Responsibilities:

  • Ensure GMP-compliant activities on the manufacturing floor through support and guidance to operations colleagues.
  • Review and approve process-related Change Requests, Deviation, OOS Investigations, CAPAs, and other related documents.
  • Contribute to contamination control and participate in contamination investigations.
  • Ensure on-the-floor execution of validation and qualification protocols.
  • Perform visual inspections on equipment and escalate material defects or malfunctions.
  • Participate in GEMBA.

Requirements:

  • Absolved technical apprenticeship is required; a degree in chemistry/biology/science or a related field is advantageous.
  • Professional experience and GMP knowledge within a GMP manufacturing facility is required, with experience in a Biologics facility being an advantage.
  • Additional experience in a GMP Quality department is an asset.
  • Proficiency in Microsoft Office suite and eQMS (Trackwise, DMS, and LIMs) is required.
  • English proficiency is essential; German fluency is advantageous.

At Lonza, we value our people and our environment. Our business results are achieved through ethical means, and we respect our responsibility to improve lives worldwide.



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