Manager - Quality Assurance

1. Review of the quality management system documents such as change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc. 
2. Handling investigations, complaints.
3. Planning, mentoring, monitoring of IPQA functions as per the procedures and CGMP compliance in the site.
4. Responsible for schedule & coordination, handling of internal audits and its documents.
5. Batch release: Review of analytical data and batch records for approval or release of products for dispatch (Batch disposition) compliant to regulatory and customer requirements.
6. Co-ordination for batch dispatch by complying the good distribution practices. 
7. Responsible for Vendor qualification of raw material, packaging material and critical service provider’s qualification for testing, calibration, validation, transporters etc.
8. Review, approval and ensure the quality agreements for all the critical material vendors, service providers and with the customers as applicable.
9. Handling of ENSUR system for issuance & retrieval of SOPs, specification, ATRs, work sheet & stability protocol management, BMR, BPR, BFR as on when required.
10. Review and or approve the quality management documents such are Process validation, cleaning validation, continuous process verification, equipment, critical utility validation / qualification, software qualification / validation, specifications, test method.
11. Review the calibration, preventive maintenance related documents, risk assessments, annual product quality reviews, site master file, quality manual, validation master plan, etc.