Job Description
Position Purpose
To support the execution of GxP audit and inspection activities across GCP, GLP, and GVP, ensuring compliance with applicable global regulations and internal quality standards, while contributing to inspection readiness and continuous quality improvement initiatives.
Accountabilities / Responsibilities
- Support and conduct GCP, GLP, and GVP audits as a lead auditor for assigned audits or as a team member, including internal processes, investigator sites, vendors, and service providers.
- Contribute to / coordinate regulatory inspection support activities (e.g., FDA, EMA, MHRA, Health Canada), including preparation, coordination, and follow-up actions.
- Support the risk-based audit programme, including audit preparation, execution, reporting, and CAPA follow-up and tracking.
- Document audit observations, assess responses, and review CAPA evidence for adequacy and timely closure.
- Provide quality and compl...