QA & CQV Specialist

Headcount AG

  • Basel
  • Freiberuflich
  • Vollzeit
  • 30 Tage her
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

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