Currently working with a Biotech Client in Switzerland who are in need of support from a QA CSV Specialist for ongoing high-level projects. In this role you will manage the CSV projects from a QA perspective.
- Managing the CSV projects independently.
- Support in different projects in lab, manufacturing, distribution, and clinical departments.
- Write risk assessments for the projects and support the validation.
- You will be the QA contact point and representant for these project so will be the go-to person for any issues. Generally, you won’t write the documentation but will support and advise Validation teams.
- Participate in internal, external and suppliers audits, working with the GxP systems and supporting the validation.
- QA background in GMP Biopharma environment with extensive knowledge of CSV, data integrity and GxP.
- Must be able to work independently with GAMP5, 21CFR Part 11, Annex11 and GxP
- You are very motivated and can prove the knowledge you have in these fields.
- Fluent in English is a must.
Duration: Between 6 and 12 months (possibility to extend)
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For more information, please contact Ivan de Marcos Ospino on +31 (0)20 20 44 502 or email@example.com