The role involves overseeing GxP impacting projects to ensure all applicable regulatory and compliance requirements are met for new or revised computerized systems
Job Summary
The role involves overseeing GxP impacting projects to ensure all applicable regulatory and compliance requirements are met for new or revised computerized systems.
Candidates will be responsible for developing and reviewing critical validation deliverables including Validation Plans, Test Protocols, Risk Assessments, and Traceability Matrices.
The position requires maintaining up-to-date knowledge of evolving regulatory requirements and acting as an information resource for delivery teams across the organization.
Matching Summary
The role involves overseeing GxP impacting projects to ensure all applicable regulatory and compliance requirements are met for new or revised computerized systems.
Skills & Requirements
Must-have
GxP regulatory compliance knowledge
Computerized system validation lifecycle
21 CFR Part 11 and Annex 11 expertise
Risk-based validation approach implementation
Validation documentation development and review
Nice-to-have
Experience with PLC controlled equipment
Strong communication and negotiation skills
Ability to influence cross-functional teams
Knowledge of EDMS, PLM, QMS, LIMS, ERP
Dedication to quality and continuous improvement
Key Requirements
Bachelor's degree in computer science, engineering, or life science
Minimum 2 years experience in equipment/process validation lifecycle management
Minimum 2 years experience in pharmaceutical or medical device industry
Excellent understanding of GxP regulations and validation standards