Job Description
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 behaviors, gowning, visual inspections, and contribute to QMS improvements (SOPs, training).
YOU...
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 behaviors, gowning, visual inspections, and contribute to QMS improvements (SOPs, training).
YOU...
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