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
My VCLS story
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