QA CSV Engineer

Source Group International; Oberwallis; On-site; CHF 120,000 - 180,000; Full time

Job summary

Source Group International seeks a senior QA professional to provide independent oversight of GMP CSV activities and data integrity remediation. The role requires navigating regulatory expectations, supervising CAPA evidence, and ensuring inspection readiness for FDA-related reviews.

The ideal candidate has extensive QA experience in computerized systems, strong knowledge of Part 11 and DI guidance, and is willing to travel to Visp (Switzerland) for on-site collaboration.

Qualifications

• Extensive independent QA oversight of GMP CSV.
• Direct FDA inspection experience on computerized systems or data integrity topics.
• Expert knowledge of Part 11, Annex 11, GAMP 5 and DI guidance.

Responsibilities

• Review scope, risk rankings, test strategy, deviations, validation reports and CAPA evidence.
• Verify independence from authors/executors and identify unresolved GMP risks.
• Review DI controls and critical electronic-record lifecycle evidence with DI specialists.
• Prepare QA-approved inspection narratives and coach SMEs; escalate deficiencies.
• Recommend acceptance/rejection; sign as approver only if Lonza delegation permits (D05).

Skills

Independent QA oversight

FDA inspection experience

Regulatory knowledge

Critical thinking / challenge justific

Tools

DeltaV

Job description

Purpose

• Provide independent quality oversight and documented challenge of OT CSV and data-integrity remediation.

Revised responsibilities

• Review/challenge scope, risk rankings, test strategy, deviations, validation reports and CAPA evidence.
• Verify independence from authors/executors and identify unresolved GMP risks.
• Review DI controls and critical electronic-record lifecycle evidence with the DI specialists.
• Prepare QA-approved inspection narratives and coach technical SMEs; escally critical deficiencies.
• Recommend acceptance/rejection; sign as approver only if documented Lonza delegation permits (decision D05).

Must-have requirements (recruitment)

• Substantial independent QA oversight of computerized systems in GMP (15+ years preferred; 10+ with strong oversight record flagged for D09).
• Direct FDA inspection experience (front room or back room) on computerized system or data integrity topics.
• Expert knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5 (Second Edition) and data integrity guidance (FDA, MHRA, PIC/S); QA experience on OT/automation systems, preferably DeltaV.
• Willing and able to travel to Visp 2 days per month. Fluent English.
• Nice-to-have: FDA 483/warning-letter remediation, biologics manufacturing, qualified GMP auditor, German.
• CV keywords: independent QA review, FDA inspection, 483, warning letter, Part 11, Annex 11, PIC/S, MHRA DI, DeltaV, CAPA.

Critical competencies

• Independent GMP QA CSV oversight and direct FDA inspection exposure; senior profile (15+ years preferred, D09 pending).
• Expert OT computerized systems, DeltaV/batch/historian control risks, Part 11, Annex 11, GAMP 5 and DI guidance.
• Ability to challenge weak risk justifications, insufficient evidence and ineffective CAPAs.

CV screening knock-out criteria (screening w/c 19-Oct-2026)

• No direct FDA inspection exposure.
• Execution-only CSV background without an independent QA oversight role.
• Not available to start between 2-Nov-2026 and 1-Dec-2026.

Minimum deliverables

• QA review log, challenge register and disposition decisions.
• Documented review of critical validation/DI packages and inspection readiness evidence.
• Escalation log and recommended acceptance/residual-risk statements.

We believe in equal opportunity for all and actively encourage applications from diverse backgrounds, experiences, and perspectives.