Audit & Capa Lead
vor 1 Woche
Salary:
Competitive
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REF Number:
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Consultant:Kajenthi Chelliah
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Contact:
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Date Published:
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Sector:
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Location:Lausanne,
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Discipline:
CK QLS are recruiting for an Audit & CAPA Lead to join a biopharmaceutical company based in Switzerland on an 8 months contract.
The Audit & CAPA Lead's Main responsibilities:
- Audit & CAPA process owner
- Ensure the riskbased audit strategy is properly applied, in close collaboration with the GxP Quality Leads and the Business Partners.
- Create & maintain global GxP audit programs (in line with business priorities and timelines) materialized by means of a Master Audit Plan.
- In line with the outsourced audit model, select qualified auditors to timely execute the agreed Master Audit Plan covering 3rd parties, systems, processes, studies, documents,etcto adequately assess compliance with DPI Procedural Documents and applicable regulations.
- Manage all audit activities starting from audit planning, preparing, execution up to delivering final report.
- Contribute to preparation and conduct activities of Regulatory Authority Inspections.
- Work with GxP Quality Lead in view of adequate and timely CAPA development.
- University degree: Pharmacist Diploma, PhD, master's in science
- Previous experience in managing quality assurance within the pharmaceutical industry and/or Biotech companies
- Experience in GxP Audits, in managing tracking systems such as CAPAs database and in using validated electronic quality systems tools (TrackWise, Veeva, Ennov, etc)
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