The QA Officer is responsible for acting as a QA coordinator within the organization, performing quality assessments on the operational processes and advising on improvements towards the departments.

Key Accountabilities

• Plan, execute and report audits according to the audit timetable and applicable procedures;
• 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 procedures 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;
• Monitor the progress, appropriateness and correct implementation of corrective measures
• Prepare, review and improve QA procedures
• Review and approve pr...