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QA Expert - Aseptic Area

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QA Expert - Aseptic Area

Kelly Scientific recruits QA Expert - Aseptic area for its biotechnology partner in Switzerland for a permanent position.

Your mission

As a member of the quality department, your mission is to act as a Quality partner for operational units.
You ensure Systems and documentation, compliance and regulatory GMP requirements.
You act as a QA representative for QA routine tasks and also QA projects.

Your responsibilities

  • Participate to the Quality activities related to the batch record review, product release, and/or raw materials (release, specification implementation, etc.)
  • For change control, review and evaluate change requests according to processes, methods, quality systems and applicable regulatory files to meet Corporate, Divisional and Regulatory requirements (incl. IND, BLA, MAA files)
  • Provide quality oversight in term of solving problems/root cause for deviation and CAPA
  • Be a leader in the implementation of facility projects in conformance with regulatory requirements
  • Be involved in preparation and/or presentation during GMP audits

Your profile

  • University Degree in Pharmaceutical Sciences, Biochemistry, Biology, or related scientific field
  • Minimum 5-year work experience within biotechnology or pharmaceutical company in QA position or QA projects
  • French mother tongue - Fluent in English - minimum B2

Your Kelly Contact

Sophie Darthenay
Consultant Professional Staffing Life Science
Kelly Scientific Geneva


rue du Rhône 114 1204 Geneve

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