The role involves directing the validation activities for computerized systems at a pharmaceutical manufacturing site in Mayenne, France
Job Summary
The role involves directing the validation activities for computerized systems at a pharmaceutical manufacturing site in Mayenne, France.
Candidates must ensure all systems comply with regulatory standards, company policies, and data integrity requirements while managing periodic reviews.
This position serves as the primary Quality Contact for central system changes and acts as the validation reference during inspections and audits.
Matching Summary
The role involves directing the validation activities for computerized systems at a pharmaceutical manufacturing site in Mayenne, France.
Skills & Requirements
Must-have
Validation of computerized systems
GAMP 5 and Annex 11 knowledge
Data Integrity requirements
IQ/OQ/PQ lifecycle management
Regulatory compliance oversight
Change management processes
Nice-to-have
Experience with Veeva or Kneat systems
Strong communication for audits
Microsoft Office proficiency
AI tools familiarity
Cross-functional team leadership
Key Requirements
Minimum 5 years experience in computerized system validation
Engineering, Life Sciences, Pharmacy, or IT degree
Pharmaceutical or highly regulated industry background