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JOB ROLES AND EXPECTATIONS:

Key Result Area

Key Roles / Duties

Quality

1. Schedule, prepare protocol/reports, and conduct process and cleaning validation.
2. Provide ongoing training, motivation, coaching, support, and correction to employees to ensure that quality standards are met.
3. Responsible for investigation of complaints and recalls in coordination with other departments.
4. Issue controlled documents e.g., specifications, BMRS, CAPA forms, Deviation reports, QC reports, preventive maintenance forms, facility layouts, SOPs, protocols etc.
5. Collect and compile statistical quality data, keeping accurate record of the same (APQR).
6. Monitor cleaning of warehouses, temperature mapping and environment monitoring.
7. Document and report quality issues to the team leaders and Section head.
8. Verify the received materials on receipt and ensure that it adheres to the defined standard specifications.
9. Preparation of documents required for regulatory affairs.
10. Monitoring and control of the manufacturing environment.
11. Checking of overprinted details and proof checking.
12. Line clearance during product change over.
13. Compliance of audit observations.
14. Ensure basic norms of cGMP are being followed at all times.
15. Ensure availability and implementation of updated and Approved SOPs in manufacturing, Quality Control, Engineering and Warehouse areas. This includes Conformance of activities with SOPs and any need to modify.
16. To check cleanliness of shop floor and auxiliary area.
17. Counter check the In-process parameters.
18. Ensure Calibration of Equipment / Instruments is regularly done.
19. Ensure manufacturing process is validated and carried out as per instructions in BMR.
20. Ensure Health, Safety and Environmental norms being followed.
21. Check Status labels, labeling of containers, equipment and materials.
22. Online documentation and timely entries of all operations /activities.
23. Participate in validation, qualification and performance verification.
24. Perform quality assurance rounds (Gemba walks).
25. Review and verification of different logs of production, packing, stores areas.
26. To review the finished goods receipt (BSR), storage, control and dispatch.
27. To participate in external calibration and thermal mapping as per schedule.
28. Ensure that FEFO and FIFO is followed.
29. Perform sampling of Bulk, Retention samples.

Health and safety

1. Identify, assess, priorities and control risks arising from operations/activities in relation to the impact on the health and safety of all staff, contractors and visitors.
2. Ensure that the work environment is safe and any health safety risks are documented and followed by all staff through appropriate tool box talks.

 AUTHORITIES:

1. Issuing controlled documents.
2. Deviation reporting on non-conforming activities.
3. Line clearance for all production activities.
4. Approval/Rejection on receipt of starting materials.