- Manage overall Quality Assurance activities of the plant.
- Ensure compliance with WHO GMP, Schedule M, IP/BP/USP and regulatory requirements.
- Prepare, review and maintain SOPs and quality documents.
- Review and approve batch records, specifications, test reports and COAs.
- Handle deviations, OOS/OOT, CAPA and change controls.
- Manage customer complaints and quality investigations.
- Coordinate and support customer, regulatory and internal audits.
- Ensure proper documentation and data integrity.
- Monitor implementation of GMP and quality systems throughout the plant.
- Coordinate with QC, Production, R&D; and Regulatory departments.
- Ensure timely investigation and closure of quality-related issues.
- Train employees on GMP, SOPs and quality procedures.
- Drive continuous improvement in the Quality Management System.