Senior QA CSV Auditor for FDA-Ready DI
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SGI is seeking an experienced QA/CSV professional to provide independent GMP QA oversight of computerized systems and prepare inspection narratives. The role requires direct FDA inspection exposure, strong knowledge of Part 11, Annex 11, and DI guidance, with DeltaV familiarity and travel to Visp (2 days/month).
The successful candidate will challenge risk justifications, validate CAPA evidence, and sign decisions only when appropriately delegated, ensuring readiness for regulatory inspections
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