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