1. Overall functioning of the Quality Control Department.
2. Responsible for authorisation of written procedures and other documents including amendments.
3. To participate and organize analytical method transfer equipment validation, Process validations, cleaning validations and change control mechanism.
4. To participate in Investigation of complaint handling.
5. Review and Approval of Stability studies protocols, retention sample records and its management.
6. Approval of microbiology laboratory procedures, protocols and practices
7. To ensure that all the equipment and instruments are in validated and calibrated state.
8. To investigate / review deviations, OOC, OOS, OOT and CAPA results (if any) and to take remedial measures.
9. To support department functions and functionaries for smooth conductance of work by
Providing and managing optimum utilization resources.
10. To participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.
11. Supporting internal customers and meeting their requirements.
12. Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
13. Responsible for inspection, investigation and re sampling in order to monitor factors which may affect product quality.
14. Conduct the trainings.
15. Responsible for the monitoring of compliance with the requirements of Good manufacturing Practice.
16. Responsible for EHS Compliance.
17. To approve specifications, sampling instructions, SOPS, GTPS, STPS and other Quality
18. To ensure the qualification and maintenance of department, premises and equipment.
19. Ensuring the goal setting for the individual team members and monitoring, guiding to reach the goals.
20. To meet the organisation goals with respect to department goals that are defined by the
21. Ensuring the lab compliance to the regulatory guidelines.
22. Ensuring the resource availability in the laboratory.
23. Any other assignment given by Executive Director