Expert Compliance Et Validation De Systèmes Informatisés H/f

MSD (Merck)

Igoville, France
Hybrid
Gamp5 knowledge required
21cfr part 11 compliance expertise
Data integrity rules application
The primary mission is to serve as the Compliance and Validation expert for computerized systems at the Igoville site

Job Summary

  • The primary mission is to serve as the Compliance and Validation expert for computerized systems at the Igoville site.
  • The role involves defining validation standards, supporting technical experts, and ensuring regulatory adherence throughout the system lifecycle.
  • Candidates must possess a Bac+5 degree or engineering diploma with at least three years of experience in the pharmaceutical industry.

Matching Summary

The primary mission is to serve as the Compliance and Validation expert for computerized systems at the Igoville site.

Skills & Requirements

Must-have

  • GAMP5 knowledge required
  • 21CFR Part 11 compliance expertise
  • Data Integrity rules application
  • 3 years pharmaceutical industry experience
  • Validation strategy definition

Nice-to-have

  • Innovative problem solving skills
  • Strong communication with inspectors
  • Excel proficiency for validation
  • Project management collaboration
  • French language capability

Key Requirements

  • Bac+3 to Bac+5 in technical, pharmaceutical, or quality fields
  • Minimum 3 years industrial pharmaceutical experience
  • Professional English proficiency required

Work Rights

Not specified

Tailored Resume

Cover Letter