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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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