Senior QA CSV Auditor — GMP/FDA Inspection Readiness

Source Group International; Oberwallis; Sur place; CHF 120 000 - 180 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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).

Connaissances

Independent QA oversight

FDA inspection experience

Regulatory knowledge

Critical thinking / challenge justific

Outils

DeltaV

Description du poste

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.