Compliance (Equipment Qualification & Validation)

Job Description:

1. Handling of Commissioning and Qualification in eVLMS.
2. Commissioning and Qualification of System using the tools and features available in eVLMS application.
3. Protocol execution and control of Commissioning and Qualification documents in eVLMS across Biocon Biologics.
4. Identification and raising deviation, change control and compiling other eGMP related documents in coordination with QA.
5. Lead for study execution and requalification activities for autoclave, formulation vessels, combi filling machines and tunnels.
6. Responsible for handling qualification documentation in Trackwise such as change controls, change actions and CAPA.
7. Coordinate and execute Equipment Qualification activities annually or as needed.
8. Maintain documentation for Validation activities, including Equipment Qualifications, Process Performance Qualification, and Cleaning Validation.
9. Follow GMP practices and internal procedures, reporting issues to superiors promptly.
10. Execute qualification activities, including pre-requisites, during and after completion.
11. Maintain pre-requisites for qualification and validation.
12. Record equipment qualification details accurately in the system.
13. Coordinate in QMS activity to ensure closure on time.
14. Organize and monitor team members to perform production activities for timely production of high-quality products, in a cost-effective manner, under safe conditions and according to cGMP requirements.
15. Strictly adhere to the Standard Operating Procedure and Good Documentation Practices.
16. Ensure production personnel strictly adhere to Standard Operating Procedure and Good Documentation Practices.
17. Ensure online documentation is practiced in production.
18. Able to represent department during external audits.
19. Knowledge in cGMP.
20. Familiar with Pharmaceutical guidelines.