Production Manager - Active Pharmaceutical Ingredients

Manager - Production ( API )

1. To be responsible for the overall activities of plant.
2. To be responsible for the production and manpower planning of plant.
3. To ensure that products are produced and stored according to appropriate procedures & documentation in order to obtain/maintain the required quality. 
4. To review and ensure the batch production records (BMR & BPR etc.) are executed as per standards.
5. To ensure that the qualification of Equipment’s and Instruments are done.
6. To ensure that the appropriate validations are done for products.
7. To check and ensure minimum stock of consumables, Log books and Status Labels.
8. Ensuring preventive maintenance of all equipment’s and instrument calibrations as per schedule.
9. Co-ordinate with service departments (QA, QC, IT, stores, E&M, EHS, projects, SCM & Finance) for various production related activities.
10. To ensure and verify the SAP stocks for RM, intermediates and FG materials
11. To attend GMP and safety trainings & implement the trainings outcome at workplace.
12. To ensure that the required initial and continual training of department personnel are carried out and adapted according to the need 
13. To check and ensure production related inputs in SAP system and FG transfer.
14. To be responsible for investigations for market complaints, deviations, quality incidents and take appropriate CAPA against the non-conformity / Root cause.
15. Participation in management reviews on process performance, quality and advocating continual improvement.
16. To be responsible for timely, effective communication and escalation process exists to raise quality issue to the appropriate levels of management.
17. To be responsible for production activities are being followed as per the pre-defined procedure and cGMP.
18. To be responsible for audit readiness and compliance within the stipulated timelines.
19. To be responsible for compliance of legal and other requirements related to ISO and OHSAS standards 
20. To be responsible for identification of risk, hazards, environmental aspects and evaluation and review the same.
21. To be responsible to develop the objective and targets under the ISO and OHSAS standards 
22. Identify the EHS training needs for awareness and competence of department personnel.
23. To be responsible for the work of his senior in the absence of senior or authorization from senior.
24. Responsible to handle all the QMS documentation works such as Change controls, Deviation investigations, Market complaint investigations, Corrective and Preventive actions, Preparation / review of protocols, Qualification & validation activities, SOP preparation or revision, Batch record preparation / review / approval.
25. Complete the assigned training activities in LMS within timeline and should provide trainings to associates as per requirement in LMS
26. Handling of Internal and External audits, Visits, Safety audits etc. and their compliance.
27. To involve in the CSV (Computer System Validation) related activities.
28. To perform review activities in ENSUR, Docusign & Trackwise system

29. To perform approval of training contents / questionnaires  in LMS