The role supports the execution of GxP audit and inspection activities across GCP, GLP, and GVP to ensure compliance with global regulations
Job Summary
The role supports the execution of GxP audit and inspection activities across GCP, GLP, and GVP to ensure compliance with global regulations.
Candidates will act as a lead auditor or team member for internal processes, investigator sites, vendors, and service providers.
The position contributes to regulatory inspection support activities including preparation, coordination, and follow-up actions for agencies like FDA and EMA.
Matching Summary
The role supports the execution of GxP audit and inspection activities across GCP, GLP, and GVP to ensure compliance with global regulations.
Skills & Requirements
Must-have
6+ years pharmaceutical industry experience
Lead auditor for GCP GLP GVP audits
Risk-based audit programme execution
Regulatory inspection support activities
CAPA follow-up and tracking
Nice-to-have
Strong stakeholder management skills
Quality culture promotion
Trend analysis and reporting
Independent task management
Willingness to travel internationally
Key Requirements
Bachelor of Science in Chemistry, Pharmacy, Biology, Life Science, Public Health, or Healthcare Provider
Master of Science or PhD preferred but not mandatory
Working knowledge of GCP, GLP, and VVP regulations
Ability to work independently with appropriate supervision