Production Head

Job Description:

1. Responsible for reviewing, approving and distributing work instruction for manufacturing activities.
2. Carry out production activities as per production plan.
3. Responsible to decide new batch production.
4. Responsible for monitoring batch process. Review online documentation related to production activities like BMR, BPRs, logbooks and daily records.
5. Qualification of production equipments and participation in validation activities.
6. To check quality system in production department.
7. To prepare equipment master list and equipment qualification plan.
8. Review of MFRs, BMRs, BPRs, SOPs and formats.
9. Review URS, DQ, IQ, OQ, PQ protocol with reports and validation protocol with reports.
10. To ensure that all production deviations are reported, evaluated and that critical deviations are investigated, and the conclusions are recorded.
11. Evaluation and investigation of all market complaints and necessary corrective and preventive actions jointly with QA.
12. Initiating any change by originating change control request and to evaluate proposed changes in product, process or equipment.
13. Review proper segregation of material, labeling and identification, area cleaning and disinfection.
14. Review Preventive maintenance and calibration done according to schedule of equipments/ utilities and recorded.
15. Check on production yields and reconciliation at various stages of manufacturing.
16. Responsible for giving training to the personnel working in the production area.
17. Responsible for handling of manpower and proper allocation of manpower.
18. Responsible for Internal audit preparation.
19. Participate in external audit preparation and handling activities during audit.
20.  To comply the requirements of technical audit.
21. cGMP documentation and their revision as and when required.

22. Identifying need and procurement of new machines and equipments.
23. Resource identification (up gradation of existing equipments and manpower).
24. Shift scheduling and sanctioning of production personnel.

To comply the requirements of safety audit