We need a person for shop floor formulation plant and tablet/capsule, The concerned person must be from a regulated Formulation Plant. He/She will be based at our Global Business Unit (GBU) in Jawaharpur, Derabassi. Responsibilities:
1. In charge for all production activities of the plant.
2. Production scheduling and control for optimum utilization of resources.
3. Performance evaluation of the resources.
4. Daily production and manpower requirement planning.
5. Dispensing plan to P.M. store and dispensing of packing materials in co-ordination with warehouse.
6. Functioning of P.M. day store and Finished good store.
7. Review and approval of all SOPs, BMRs, BPRs, Validation / qualification protocols and other documents.
8. Keep myself updated on regulatory regulations.
9. To initiate review the change control/deviation for impact assessment and execution of change control or corrective/preventive action after approval there upon.
10. To investigate market complaints and CAPA there upon.
11. To review the annual preventive maintenance planner along with engineering department.
12. To review and approve annual product review and site master file.
13. To lead the visit of statutory agencies in plant.
14. To prepare the budgetary requirements of the plant.
15. Responsible for GMP compliance in the section.
16. Member for validation and qualification team.
17. Training and development of the technical and non-technical work force.
18. To keep the record of all work in process.
19. Co-ordination with warehouse, engineering, PPIC, RA, QA, QC, HR for smooth functioning of the production block.
20. Implementation of organizational policies.
21. Responsible to ensure that products are produced and stored according to approved documentation.
22. To ensure that appropriate validations & qualifications are performed.
23. To approve the instruction relating to production operations and to ensure their strict implementation.
24. Responsible to check the maintenance of department, premises & equipments
25. To ensure that the required initial and continuing training of department personnel is carried out and adapted according to need.
26. Monitoring and control of the production requirement.
27. The authorization of written procedures and other documents, including amendments.
28. To strictly follow master documents (BMR/BPR/QSD) instructions. In case of any issue, raise deviation / change control for investigation and taking remedial action.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Packaging
Role: Packaging Development Executive/Manager
Employment Type: Permanent Job, Full Time