Responsable Qa Validation Syst. Informatisés H/f

GSK

Mayenne, France
5 years experience in computer system validation
Knowledge of gamp 5 and annex 11 regulations
Experience with data integrity requirements
The role involves directing computer system validation activities for a pharmaceutical manufacturing site in Mayenne, France

Job Summary

  • The role involves directing computer system validation activities for a pharmaceutical manufacturing site in Mayenne, France.
  • Candidates must ensure regulatory compliance and data integrity while managing periodic reviews and audit trail processes.
  • The position requires acting as the primary Quality contact for central system changes and serving as the reference during inspections.

Matching Summary

The role involves directing computer system validation activities for a pharmaceutical manufacturing site in Mayenne, France.

Skills & Requirements

Must-have

  • 5 years experience in computer system validation
  • Knowledge of GAMP 5 and Annex 11 regulations
  • Experience with Data Integrity requirements
  • Fluency in English oral and written
  • Supervision of validation documentation approval

Nice-to-have

  • Experience with Veeva or Kneat systems
  • Familiarity with AI tools
  • Strong influence and communication skills
  • Experience leading cross-functional teams
  • Participation in communities of practice

Key Requirements

  • Minimum 5 years in CS validation within pharma
  • Engineering or Life Sciences degree required
  • Practical knowledge of IQ/OQ/PQ lifecycle
  • Experience with CAB & eCAB change management

Work Rights

Not specified

Tailored Resume

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