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Job

SENIOR QUALITY ASSURANCE SCIENTIST | Lausanne

Lausanne

Role

  • Set-up and/revision of quality systems for EU & US clients • QMS gap analysis
  • Conduct audits at pharma/biotech manufacturing sites (remote and onsite) on behalf of clients
  • Support clients during authority inspections
  • Conduct mock inspections
  • Act as Swiss RP/FvP of Deputy RP/FvP as interim or permanent solution for clients
  • Contribute to the further development of QA services within VCLS
  • Provide ad-Hoc QA support to clients
  • Support CMS team

Required

  • Degree in Chemistry, Biology or equivalent
  • 5+ yeas experience in QA/Quality Management in Pharmaceutical and/or Biotechnology industry
  • Deep knowledge of EU and/or US pharmaceutical quality systems
  • Experience in set-up and/or revision of quality systems for pharmaceutical/biotech companies in EU and/or US
  • QA Gap analysis • Knowledge of Pharmaceutical compliance processes (deviations, complaints, change control, CAPA etc.)
  • Experience in conducting audits at pharma/biotech manufacturing sites and/or GLP laboratories, wholesaler or distributor
  • Experience with local and international authorities
  • Experience of hosting authority inspections
  • Eligible to act as Swiss RP/FvP is a plus
  • Experience in Regulatory Affairs and/or CMS is a plus
  • Degree in Chemistry, Biology or equivalent
  • 5+ yeas experience in QA/Quality Management in Pharmaceutical and/or
  • Biotechnology industry

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