GMP Compliance Floor Support

Vor 3 Tagen

Visp, Schweiz Lonza Vollzeit

Are you a motivated individual looking for a challenging role in a state-of-the-art Biologics Drug Substance facility? We are seeking a highly skilled GMP Compliance Floor Support specialist to join our team at BioAtrium.

BioAtrium is a dynamic organization with a focus on delivering high-quality products. As a key member of our team, you will be responsible for ensuring GMP compliant activities on the manufacturing floor and providing real-time oversight and support for colleagues within operations.

Main Responsibilities:
  • GMP Compliance: Ensure GMP compliant activities on the manufacturing floor and support operations colleagues in achieving this goal.
  • Document Management: Support in reviewing and approving process-related Change Requests, Deviation, OOS Investigations, CAPAs, and other related documents.
  • Contamination Control: Contribute to ensuring contamination control and participating in contamination investigations.
  • Protocol Execution: Ensure on-the-floor execution of validation and qualification protocols.
  • Equipment Monitoring: Perform regular visual inspections on equipment.
  • Error Reporting: Escalate any identified material defect or malfunction issues witnessed within the facility.
  • Team Collaboration: Participate in GEMBA and contribute to a collaborative team environment.
Requirements:
  • Absolved technical apprenticeship is required; a degree in chemistry/biology/science or a related field is an advantage.
  • Professional experience and GMP knowledge within a GMP manufacturing facility is required; experience in a Biologics facility is an advantage.
  • Additional experience in a GMP Quality department is an advantage.
  • Proficiency in Microsoft Office Suite and eQMS (Trackwise, DMS, and LIMs).
  • Excellent English language skills are required; German fluency is an advantage.
  • Flexibility to work irregular hours including occasional Saturdays and 5 Sundays a year.

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