Main Duties and Responsibilities Plans, leads, conducts and reports audits in all or some of the GxP areas, and types e.g. GLP facility and study audits, investigator site audit, system or process... audits and vendor audits.
Participate in and may lead directed (For Cause) audits.
Assesses need for, and assists in facilitating development of, and approves CAPA plans
Maintains and updates the audit management system in a timely manner
Works with QA lead to manage regulatory inspections as assigned including provided training to the organisation as needed.
Involved and may lead ... a scientific discipline or qualified professional in compliance, law, regulations related to area of accountability
Established GLP/ GCP / GPvP QA professional
Knowledge of Design and Conduct of Audits...