QA – Qualification & Validation Specialist (f/m/d)
We’re seeking a QA / QV Specialist to support our client in the Basel area with qualification, validation, and cleaning validation across GMP-critical systems, infrastructure, and CAPEX projects. You’ll ensure compliance throughout the equipment and facility lifecycle.
Your Responsibilities:
- Oversee and approve qualification/validation activities (URS, DQ, IQ, OQ, PQ)
- Maintain GMP compliance via change control, deviations, and requalification
- Develop and execute cleaning validation protocols (incl. swab/rinse sampling, recovery studies)
- Support CSV activities and system lifecycle documentation
- Review and approve SOPs, protocols, and reports
- Translate Annex 1 requirements into practical QA measures
- Support audits and inspections
- Contribute to mid- to large-scale CAPEX and cleanroom projects
Your Profile:
- Degree in life sciences or engineering
- Experience in GMP-regulated environments with focus on QA and QV
- Solid knowledge of cleaning validation, Annex 1, and ideally CSV
- Experience with cleanrooms, utilities, and contamination control
- Good communication skills (German / English)
Only candidates eligible to work in Switzerland will be considered.
headcount AG