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1. Responsible for indenting, approving and receiving of batch production records, cleaning records and packing records as per production requirement.
2. Responsible for raise the raw material indent and approving of indented raw materials as per production planning.
3. Responsible for Maintain good Housekeeping in the plant environment.
4. Responsible for to coordinate cross functional team to execution the plant operations smoothly.
5. Responsible for monitoring the equipment utilization and manpower distribution for effective utilization.
6. Responsible for initiation, review and approve the indents i.e., procuring production needs to run smooth production.
7. Responsible for monitor all the schedules implementation (Production planning, Preventive maintenance, calibration etc.)
8. To ensure the compliance of production activities.
9. Responsible for production planning and meet the target time lines.
10. To monitor and close the QMS documents.
11. To involve / participate in Internal Audits.
12. To extend support for customer audits / regulatory audits.
13. To involve qualification activity.
14. To give training to shop floor team.
15. To ensure the safety rules and regulations in the team during perform the work.
16. Attending training programs (GMP, job training & safety) as per the schedule.
17. Review of completed batch production records, equipment log book and shift handover log book regularly.
18. To monitor the online BPR entries and new products training before execution of the batch.
19. Responsible for preparation, review and approval of all controlled documents relating to the quality of API’s and intermediates. (Standard operating procedures, batch production records, forms, protocols, reports etc.).
20. Responsible for initiation, timely implementation, effectiveness and closure of QMS activities like change control, deviation, OOS, investigation and CAPA.
21. Review of all type of validation protocols and reports including campaign reports.
22. In the absence of immediate superior, shall be responsible for his activities.
23. To perform any other activity assigned by the superior / Plant Head.
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