Plan, execute and report audits according to the audit timetable and applicable procedures for the organization, subcontractors, suppliers, and other Eurofins Central Laboratory contacts.
Plan and execute protocol, laboratory and supporting data, and final report (interim, draft, final) audits and conduct in-life phase inspections as required for compliance with internal SOPs and bioanalytical method validation guidelines (FDA, EMA).
Perform review of raw data against the draft reports of bioanalytical studies to verify that the reports accurately and completely reflect the raw data generated.
Perform in life and operational spot inspections- generation of associated reports.
Monitor the progress, appropriateness and correct implementation of corrective measures.
Prepare, review and improve QA procedures.
Review procedures of other departments within the organization.