Manager Production - Injectable Facility

Roles and Responsibilities

Note: Experience in CNC/ Autoclave /Filling & Sealing / QMS/ Lyophilizer / Terminal Sterilizer / Tunnel Sterilizer and from USFDA approved Pharmaceutical Industries

1. Day to day planning, target achieving in monthly production plan

2. Proper coordination and communication with other departments for better execution of processes.

3. Prepare Machine URS / DQ and execute the qualification of IQ/OQ/PQ.

4. Preparation of SOP's and master batch packing record.

5. Handling of batch activity like- Media fill, Scaleup/Engineering, Exhibit, PPQ and commercial batches.

6. Ensure the completion of batch as per the production plan, Control on daily production output.

7. Review and Compliance of executed Batch Record and submit to QA in within time.

8. Immediate information to superiors in case of any anomalies found in the process.

9. Overseeing production related tasks including planning, control and troubleshooting.

10. Setting up production targets and achieving the same within time and cost parameters.

11. Optimising man & machine utilization to achieve pre-set production targets.

12. Any other job assignment allocated by site head.

13. Documents preparation and changes in existing documents as per USFDA and cGMP requirements.

14. Responsible for investigation of non-conformities, identification of root cause, suggestion of CAPA, preparation review and compliance of investigation reports.

15. Responsible for raising and execution of change control and CAPA and its implementation through eQMS software.

16. Responsible for preparation and review of Risk assessment related to process and product attributes.

17. Maintained the discipline in the departments.

Desired Candidate Profile

Perks and Benefits