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.
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QA CSV Engineer in Martigny-Ville Arbeitgeber: Source Group International
Als Arbeitgeber im dynamischen Fintech-Sektor in München bietet Source Group International eine inspirierende Arbeitsumgebung, die Innovation und Zusammenarbeit fördert. Unsere Mitarbeiter profitieren von flexiblen Arbeitszeiten, kontinuierlichen Weiterbildungsmöglichkeiten und einem starken Fokus auf persönliche Entwicklung. Bei uns haben Sie die Möglichkeit, an spannenden Projekten zu arbeiten und Ihre Fähigkeiten in einem unterstützenden Team weiterzuentwickeln.
Kontaktdaten:
Source Group International Recruiting-Team
