The role focuses on overseeing GxP impacting projects to ensure computerized systems are defendable during inspections and fit for purpose
Job Summary
The role focuses on overseeing GxP impacting projects to ensure computerized systems are defendable during inspections and fit for purpose.
Candidates will be responsible for implementing risk-based validation approaches and managing the full lifecycle of validation deliverables including test plans and reports.
The position requires maintaining up-to-date knowledge of evolving regulatory requirements and acting as an information resource for delivery teams.
Matching Summary
The role focuses on overseeing GxP impacting projects to ensure computerized systems are defendable during inspections and fit for purpose.
Skills & Requirements
Must-have
GxP regulatory compliance knowledge
Computerized system validation lifecycle
Risk-based validation approach implementation
21 CFR Part 11 and Annex 11 expertise
Validation documentation development and review
Nice-to-have
Experience with EDMS and PLM systems
Strong communication and negotiation skills
Ability to manage complex project milestones
Supplier assessment and risk management
Coaching implementation teams on validation
Key Requirements
Bachelor's degree in computer science, engineering, or life science
5 years experience with CSV validation lifecycle management
2+ years pharmaceutical or medical device industry experience