Computerized System Validation Manager

Sanofi UK

Le Trait, France
Base: €42,400.00 - €56,533; bonus/equity: not spec...
Onsite
Computerized system validation experience in pharmaceutical industry
Gmp, gamp, and 21 cfr part 11 compliance knowledge
Ot system lifecycle management and risk assessment
The role involves developing and implementing CSV strategies for OT systems while ensuring compliance with GMP, GAMP, and 21 CFR Part 11 regulations

Job Summary

  • The role involves developing and implementing CSV strategies for OT systems while ensuring compliance with GMP, GAMP, and 21 CFR Part 11 regulations.
  • Candidates will lead CSV activities including risk assessments and data integrity measures to support the continuous improvement of manufacturing processes.
  • Sanofi offers a global environment where employees can utilize AI, robotics, and automation to redefine drug manufacturing and distribution at scale.

Matching Summary

The role involves developing and implementing CSV strategies for OT systems while ensuring compliance with GMP, GAMP, and 21 CFR Part 11 regulations.

Salary

Base: €42,400.00 - €56,533; Bonus/Equity: Not specified; Benefits: Company employee benefit programs eligible

Skills & Requirements

Must-have

  • Computerized System Validation experience in pharmaceutical industry
  • GMP, GAMP, and 21 CFR Part 11 compliance knowledge
  • OT system lifecycle management and risk assessment
  • Data integrity measures implementation for OT systems

Nice-to-have

  • Leadership and results-oriented approach
  • Experience with Industry 4.0 technologies
  • Global network participation and knowledge sharing
  • Continuous process improvement mindset

Key Requirements

  • Scientific or Computer Science degree (Bac +5 minimum)
  • Minimum experience in pharmaceutical computerized system validation
  • Fluency in English (reading, writing, and speaking)

Work Rights

Not specified

Tailored Resume

Cover Letter