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 procedures of other departments within the organization
- Provide quality-enhance training on your own initiative and on request
- Act as a contact person for quality questions from the organization
- Assist with the preparation and hosting of client audits and/or regulatory inspections;
- Review and evaluate adequacy of investigations and CAPA (corrective actions/preventive actions) reports.
- Maintain current knowledge of standard requirements according to GCLP, GCP, GMP, CAP, ISO17025 and ISO 15189 guidelines related to the business process
- Archive and document control duties as assigned by QA Manager
- Perform other related tasks that match training and experience on request of the QA Manager