Anna Hrehlevych
ConsultantJob Description
- Provide independent quality oversight and documented challenge of OT CSV and data-integrity remediation.
- 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; escalate critical deficiencies.
- Recommend acceptance/rejection; sign as approver only if documented Lonza delegation permits (decision D05).
- 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.
- 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.
- 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.
- 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.
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Source Group International Ltd is acting as an Employment Business in relation to this vacancy