QA Operation Specialist

Gefunden in: beBee S CH - vor 3 Wochen

Corsiersurvevey, Schweiz Randstad Vollzeit

As a member of the Quality Operations team, you will be the QA Operation Specialist to ensure the compliance of manufacturing activities on the Corsier-sur-Vevey site.

As part of this team, you will work in close contact with Production Department by:

  • Being the QA referent for the deviations
  • Evaluating and closing minor/major deviations, supporting the related investigation, and identifying recurrences
  • Assisting in the definition of corrective and preventive actions (CAPA)
  • Reviewing production batch records
  • Reviewing and approving quality risk analyses
  • Reviewing and approving cGMP documentation related to production activities (procedures, specifications, reports, process control strategies, etc.)
  • Reviewing, approving, and following the Change Control Proposals (CCP) and ensuring their correct implementation
  • Participate in health authority inspections, corporate audits and internal or external audits.

    Qualifikationen

    Your profile:

    • Scientific education (master preferred or equivalent profile of experience) in biology, chemistry, pharmacy engineering or equivalent
    • At least 3 years' experience in the pharmaceutical or biopharmaceutical industry on a GMP manufacturing site.
    • You have a very good knowledge of Good Manufacturing Practices (cGMP)
    • You have good technical knowledge of bioreactors, cell culture, protein purification and working in a controlled atmosphere environment.
    • You are familiar with investigation tools, and you demonstrate excellent analytical skills
    • You are familiar with computer tools, particularly Trackwise and SAP.
    • You have an excellent level of French (mandatory) and English
    • You are proactive in the implementation of improvements, solution oriented and the ability to adapt to changes.
    • You are a team player and you have very good communication skills

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