QA Operations Engineer; HC)

• Embed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight.

• Embed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight.

• 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.

• 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 e  review, FDA inspection experience, Lean/Six Sigma, Veeva or Track Wise.
• CV , e , deviation, CAPA, biologics, 21 CFR 210/211, EU GMP, Track Wise, Veeva.

• Direct QA Operations experience in GMP biologics manufacturing; 8+ years or equivalent depth (thresholds under D09).
• Batch record/e  review, deviation investigations, CAPA and operational change control.
• Ability to interpret DeltaV/MES-generated batch exceptions with qualified SMEs; onsite work eligibility in Switzerland.

• 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.

• 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.