Audit & CAPA Lead
CK QLS are recruiting for an Audit & CAPA Lead to join a biopharmaceutical company based in Switzerland on a permanent contract.
The candidate will join their Quality department based in Lausanne. The company is specialised in oncology and infectious diseases in order to improve patient outcomes and quality of life. The company aims to fight against cancer and infectious disease and to develop innovative therapies that target high unmet medical needs.
The Audit & CAPA Lead’s Main responsibilities:
- Audit & CAPA process owner
- Ensure the risk-based 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, etc… to 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)
Please could you send any correspondence in English. Please contact Adrien Guimard by phone 0041 (0) 800 106 106 or by email to firstname.lastname@example.org. Please quote job reference 54965 in all correspondence.