- Embed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight.
Purpose
- Embed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight.
Revised responsibilities
- Review batch records and automation-generated batch exceptions, escalating unexplained gaps or discrepancies.
- Support deviations, root cause, CAPAs, change control and effectiveness checks.
- Conduct GMP walkdowns and assess temporary manual workarounds and contemporaneous documentation.
- Work with automation/DI SMEs on recipe changes, alarm/event histories, historian evidence and batch record reconciliation.
- Support inspection walkthroughs and disposition documentation without assuming batch release authority.
Must-have requirements (recruitment)
- 8+ years (or 5+ with strong biologics floor experience, flagged for D09) in QA Operations within GMP biopharmaceutical manufacturing.
- Working knowledge of 21 CFR 210/211 and EU GMP; hands-on deviation, CAPA and batch record review.
- Eligible to work in Switzerland and able to work full time on site in Visp. Fluent English.
- Nice-to-have: German, mammalian cell-culture drug substance, DeltaV/MES eBR review, FDA inspection experience, Lean/Six Sigma, Veeva or TrackWise.
- CV keywords: batch record review, eBR, deviation, CAPA, biologics, 21 CFR 210/211, EU GMP, TrackWise, Veeva.
Critical competencies
- Direct QA Operations experience in GMP biologics manufacturing; 8+ years or equivalent depth (thresholds under D09).
- Batch record/eBR review, deviation investigations, CAPA and operational change control.
- Ability to interpret DeltaV/MES-generated batch exceptions with qualified SMEs; onsite work eligibility in Switzerland.
CV screening knock-out criteria (screening w/c 19-Oct-2026)
- No QA Operations experience in GMP biologics manufacturing.
- Not eligible to work in Switzerland, or unable to work full time on site.
- Not available on any of the listed start dates.
Minimum deliverables
- Reviewed batch records/exception logs and documented escalations.
- Deviation/CAPA reviews, floor-readiness observations and closure evidence.
- Inspection walkthrough readiness and prioritized open-quality issues.
We believe in equal opportunity for all and actively encourage applications from diverse backgrounds, experiences, and perspectives.
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QA Operations Engineer (1 HC) Arbeitgeber: SGI
Als führendes Unternehmen im Finanzdienstleistungssektor in Deutschland bietet unsere Organisation nicht nur eine spannende Rolle als SailPoint Engineer, sondern auch ein dynamisches Arbeitsumfeld, das Innovation und Zusammenarbeit fördert. Wir legen großen Wert auf die berufliche Weiterentwicklung unserer Mitarbeiter und bieten zahlreiche Schulungs- und Aufstiegsmöglichkeiten, um Ihre Karriere voranzutreiben. Darüber hinaus profitieren Sie von einer positiven Unternehmenskultur, die Vielfalt schätzt und ein ausgewogenes Verhältnis zwischen Berufs- und Privatleben unterstützt.
