- Management of CAPA from tracking, including follow-ups and closure.
- Management of Change Control, Deviations, from tracking, follow-ups and closure.
- Review quality process control plan, drive quality issues to root cause, corrective actions and improvements.
- Perform, document internal audits and other quality assurance activities to ensure readiness on international standards certification audits and GMP inspection.
- Coordinate and assists during customer visits and audits.
- Create, review work instructions and standard operating procedures, devise sampling procedures and directions for recording and reporting quality data.
- Review the implementation and efficiency of quality and inspection systems.
- Collect, compile statistical quality data, and analyze data to identify areas for improvement in the quality system.
- Review of analytical reports, and batch records (manufacturing and packaging).
- Perform SAP QM setting, review test results, block / unblock of finished products.
- Manage customer queries, customer satisfaction surveys, and questionnaires and other quality / regulatory purpose documentation requests.
- Investigate customer complaints and non-conformance issues.
- Consolidate data to create the annual product quality review report.
- Track quality performance and initiate quality improvement plans.
- Perform risk assessments and monitor risk management activities at quality level.
- Conduct / perform training to employees to improve GMP / international standards certification awareness and compliance.
- Perform any other duties and responsibilities as assigned from time to time.
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