General Manager- Production

Role & responsibilities:

1. Planning and upward approval of various development activities for capacity enhancement and cGMP.

2. To facilitate various on-going development activities.

3. Ensure the available resources (man, machine, & Energy) optimization and utilization. Continuous improvement in production activity to provide the safe and healthy working environment.

4. Ensure smooth production planning in production as per the requirements v/s capacities. To ensure that all production targets are achieved within desired timelines.

5. To Review and Approve Artworks

6. To coordinate with Engineering/ projects/R&D teams for smooth execution and completion of

projects in plant.

7. To check and review the project related drawing for area/equipment's feasibility and any

modifications/ deletions required for the same.

8. To Check and Review QMS documents (Change Controls, Deviations Incidences, CAPA etc.)

9. To check and review the master documents like - SOP'S, BPR, Qualification protocol, etc.

10. To check and review the new and revised BPR's documents uploaded in open text.

11. Ensure that periodic checking and review SOP's to comply the cGMP Guidelines.

12. Routine and time to time reports and feedbacks to the upward management for the evaluations and corrective actions there upon.

13. To co-ordinate the service oriented department likes Engineering, QA, QC, Warehouse, PPIC, HR and Administration for better planning and execution.

14. Evaluation of daily & periodically work done and subsequent guidance and instructions to the

subordinate, executives and other staff.

15. To facilitate technology transfer from R & D to the extent of robust manufacturing processes with taking care of various technical issues.

16. To provide shop floor training to subordinates and down the line employee.

17. To ensure the compliance of cGMP at every stage.

18. To comply the regulatory requirement as per regulation and to present the facility to the auditors.

19. To safe guard the equipment's for smooth functioning. provide necessary for preventive maintenance Calibration, and qualification and validation activities.

20. Support to HR for selection process of new recruitment employee in production.

21. To provide necessary Support to Internal and External Audit.

22. Preparation of Annual Budget for Formulation. ensure proper utilization of capex and opex budget.

23. Responsible for risk and aspect, impact assessment system.

24. Ensure Daily production report.

Preferred candidate profile:

Educational Qualifications

B Pharm M Pharm

Experience

18+ Years experience in Production

Knowledge and Skills (Functional / Technical)

Regulatory Authorities Exposure, USFDA Audits, Formulations Manufacturing

Perks and benefits