Onsite GMP QA Operations Engineer — Biologics & Batch Review
Source Group International
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Job summary
Source Group International is seeking an experienced QA Operations professional to embed on-site QA support within GMP biologics manufacturing in Visp, Switzerland. You will review batch records, deviations and CAPAs, working with automation SMEs to reconcile batch data and ensure compliance.
The role requires 8+ years in QA Operations, strong knowledge of 21 CFR 210/211 and EU GMP, and full-time on-site availability in Visp. Fluent English is essential; German is a plus.
Qualifications
- 8+ years in QA Operations within GMP biopharmaceutical manufacturing.
- Hands-on deviation, CAPA and batch record review experience.
- Eligible to work in Switzerland and on-site in Visp; fluent English.
- Nice-to-have: German, mammalian cell-culture, DeltaV/MES eBR review, FDA inspection exposure.
Responsibilities
- Review batch records and automation-generated batch exceptions, escalating gaps or discrepancies.
- Support deviations, root cause analysis, CAPAs, change control and effectiveness checks.
- Conduct GMP walkdowns and assess temporary manual workarounds and contemporaneous documentation.
- Collaborate with automation/DI SMEs on recipe changes, alarm/event histories, historian evidence and batch record reconciliation.
- Support inspection walkthroughs and disposition documentation without batch release authority.
Skills
Tools
Job description
Source Group International is seeking an experienced QA Operations professional to embed on-site QA support within GMP biologics manufacturing in Visp, Switzerland. You will review batch records, deviations and CAPAs, working with automation SMEs to reconcile batch data and ensure compliance.
The role requires 8+ years in QA Operations, strong knowledge of 21 CFR 210/211 and EU GMP, and full-time on-site availability in Visp. Fluent English is essential; German is a plus.
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