Roles and Responsibilities1. Planning, Implementation and compliance of QMS system. 2. Adherence to safety and quality policies and provide necessary support at all time. 3. Ensure the adherence to cGMP and regulatory guidelines and SOPs by the plant personnel. 4. To conduct the Quality review meeting and monitor the QMS activities for timely closer. 5. Review and approval of core technical documents leading the Audit compliance QMS, Documentation, validation. 6. To monitor & Conduct external/Internal/vendor & Contract manufacturing audits as per schedules. 7. Review & management of technology Transfer of products. 8. Overall monitoring of new product introduction through technology transfer process. 9. Review and approval of product quality related Documents (product quality review Annual product quality review, Stability data .BMR/BPR and artwork coordinate the document submission for regulatory approvals. 10. To ensure batch records review and release of finished product. 11. To ensure stability management programme of dosage forms. 12. To approval of protocols reports validation qualification activities. 13. To Ensure calibration and Preventive maintenance planner and its compliance. 14. To identify the resources for QA and QC functions and ensure optimum utilization. 15. To Form the investigation team and monitor the effective CAPA associated with Incident OOS,OOT, OOE,OOC complaints, recalls. 16. To review and assess the trend analysis reports. 17. To ensure the compliance of the corrective and preventive action (CAPA) necessitated through various. activities such as regulatory audit, market complaints APQR and Product Recall. 18. Communicate the major product quality related issues to management and regulatory agencies. 19. Host the Regulatory & customer audit and preparation, review and timely submission of audit compliance report. 20. Identification, evaluation and approval outside testing laboratory. 21. To ensure the compliance of safety requirement, Hygiene and environment in the working area. 22. Coordinate the vendor qualification activities and review the technical agreement. 23. Ensure timely notification to customers and field alert reporting on incidents impacting product quality. 24. Responsible for personnel qualification and for people involved in manufacturing and QC operations. 25. Responsible for technical training of personnel involved in GMP operations.
Job Title
Head & DGM - Quality Control