QA Quality Engineering

Shape the future of industrial technology with Techfirm Engineering

For our Industrial Services team, Techfirm Engineering is looking for a
QA Quality Engineering (C&Q) Specialist
ready to take on exciting challenges and grow with us in the German-speaking part of Switzerland.

KEY RESPONSIBILITIES

• Review and approve C&Q documentation including URS, risk assessments,
  DQ/IQ/OQ/PQ protocols
  , test plans, deviations, and change controls according to GMP/FDA standards.

• Execute and document commissioning, qualification, and validation activities for
  equipment, clean utilities, and cleanrooms
  , including FAT/SAT execution and reporting.

• Conduct risk analyses (FMEA), GAP analyses, ensure GMP compliance (EU GMP Annex 1, FDA 21 CFR Part 210/211, ISPE Baseline Guides, GAMP 5), and manage CAPAs/non-conformities.

• Provide
  hands-on QA support
  in aseptic manufacturing: monitor cleanroom be...