Job Description

Department Details

Role Summary

Injectable-Line incharge & QMS

Key Responsibilities

1. Responsible for Preparation of URS for all the Equipment’s and instruments – injectable facility

2. Handling Training requirement.

3. To prepare and review of qualification and other miscellaneous protocols.

4. To prepare and review Process and Packaging Validation protocol or report.

5. To prepare and review BMR/BPR for different products.

6. To initiate and work upon Operational Excellence projects.

7. To initiate and work upon Operational Excellence projects

8. To ensure the compliances of the documents and practices

9. To handle the LMS, SAP and Track wise elements online

10. Preparation and review of Facility Layouts – Men, Material flow, semi-finished and finished products flow.

11. Indenting support and procurement in SAP coordination for the operation

12. Coordinate with Cross functional Team for process design meeting the regulatory requirement

13. All the Equipment’s or instrument in operation of suitable capacity, current GMP compliant

14. Preparation of SOPs, Protocols, batch records and QMS documents like change controls, CAPA, deviations and other quality documents, whenever required.

15. Adherence to safety, Health and Environment norms for this project.

16. To coordinate with supporting departments i.e. QA, QC, Engineering &Maintenance, for achieving the day-to-day targets and compliance

17. Completing the qualifications of equipment’s coordinating with cross functional team as per the project timelines.

18. Ensuring the set targets of Production and deliveries as per norms of quality, cost and efficiency

19. Responsible for manufacturing operations

20. Ensure the operation, cleaning of area and equipment’s in compliance state.

Educational Qualifications

Required Education Qualification: B.pharma
Required Experience: 7 – 12 years