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Join the Quality Assurance team in Stein, supporting critical QC microbiology operations and driving the QA implementation of gLIMS for pharmaceutical manufacturing. This role is primarily based on site, enabling close, real-time collaboration and technical precision to ensure the highest quality and safety standards in medicine manufacturing.

Tasks

  • Provide direct QA oversight and technical guidance to the Quality Control Microbiology department to ensure full GMP compliance.
  • Serve as the primary QA point of contact and subject matter expert for the implementation of gLIMS (Laboratory Information Management System) and laboratory execution systems.
  • Review and approve GMP-relevant documentation, with a primary focus on SOP revisions and gLIMS integration.
  • Manage and execute core quality compliance activities, including deviations (DRs), change controls (CRs), and document management.
  • Oversee raw data review and support the review, approval, and release of batch-related microbiology documentation.
  • Maintain and report departmental Quality KPIs to drive operational excellence and continuous improvement.
  • Support site readiness and represent QA during health authority inspections and internal quality audits.

Requirements

  • 2+ years of experience in laboratory execution systems (gLIMS/LIMS) implementation within a regulated GMP environment.
  • 7+ years in QA/QC role.
  • Deep expertise in cGMP regulations and international standards, including US, European, and Japanese Pharmacopoeia.
  • Proven experience with laboratory equipment qualification, software validation, and data integrity standards.
  • Strong background in QC microbiology processes, batch release procedures, and root-cause investigation tools.
  • Demonstrated success interacting with health authorities (e.g., FDA, Swissmedic) during regulatory audits.
  • Pragmatic, solution-oriented mindset with excellent organizational skills and a structured approach to problem-solving.
  • Professional fluency in English.
  • German language skills preferred and project management certification (e.g., Green/Black Belt) are strong advantages.

Benefits

  • An agile career and dynamic working culture.
  • An inclusive and ethical workplace.
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Über uns
Lonza Group AG ist ein international tätiges Unternehmen für die Pharma-, Biotech- und Life-Science-Industrie. Das Unternehmen entwickelt und produziert Wirkstoffe, biopharmazeutische Produkte sowie spezialisierte Lösungen und unterstützt Kunden von der frühen Entwicklung bis zur industriellen Herstellung. Zudem stellt Lonza chemische und biotechnologische Komponenten für Anwendungen in Gesundheit, Ernährung und weiteren Industrien her.
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