Onsite GMP QA Operations Engineer – Biopharma

SGI; Oberwallis; On-site; CHF 110,000 - 150,000; Full time

Job summary

SGI in Visp, Switzerland seeks an experienced QA Operations professional to embed onsite QA support into GMP Biopharma shop-floor operations. The role focuses on automation-related batch quality oversight, batch record review, deviations, CAPA and change control to ensure compliant manufacturing.

You will collaborate with automation/DI SMEs, review exceptions, support inspections, and maintain contemporaneous documentation. Fluent English required; German nice-to-have.

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 onsite in Visp.
• Fluent in English; German is a plus.

Responsibilities

• Review batch records and automation-generated batch exceptions; escalate gaps.
• Support deviations, CAPA, change control and effectiveness checks.
• Conduct GMP walkdowns and assess temporary manual workarounds.
• Collaborate with automation SMEs on recipe changes and batch reconciliation.
• Support inspection readiness and disposition documentation without batch release authority.

Skills

Batch record review

Deviation investigations

CAPA

Operational change control

GMP biopharma

Tools

DeltaV/MES

eBR

TrackWise

Veeva

Job description

SGI in Visp, Switzerland seeks an experienced QA Operations professional to embed onsite QA support into GMP Biopharma shop-floor operations. The role focuses on automation-related batch quality oversight, batch record review, deviations, CAPA and change control to ensure compliant manufacturing.

You will collaborate with automation/DI SMEs, review exceptions, support inspections, and maintain contemporaneous documentation. Fluent English required; German nice-to-have.