Job Description

Department DetailsRole Summary1. Ensure quality oversight on all QMS documents and systems, to ensure consistency of global standards, harmonization, sharing of best practice and productivity.
3. Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements.
4. Conduct Quality reviews to evaluate if process and deliverables fulfills requirements of quality.
5. Involve in regulatory, customer and internal audits.
6. Ensure system of issuance, retrieval and archival of documents is in place and routinely followed.
7. Ensure registration of Quality Events timely as per the approved procedures.
8. Review of Investigation reports for data furnished for correctness of statements, evidence-based review and ensure no errors in the data and conclusions derived.
9. Review of CAPA for effectiveness and negative impact and ensure closure in time.
10. Involve in Investigation of Out of Specifications and ensure the investigations are timely conducted and root cause analysis is adequately carried out.
11. Assessment of change controls for impact and review of mitigation plans for risk identified, ensure changes are implemented timely and closed.
12. Assessment of Event for Impact, Investigation mechanism and scientific aspects.
13. Trending of Deviations, change controls, CAPA and OOS and assessment for effectiveness of quality procedures for events and propose recommendations based on observations.
14. Making sure that quality related complaints are investigated and resolved.
15. Reviewing and approving procedures, validation protocols and reports.
16. Performing product quality reviews. Evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables,
and to identify strengths and opportunities for improvement.
17. To support the development and delivery of training in quality function.
18. Involve in management review meetings to identify opportunities for continual improvement of Quality Management system.
19. Release/Reject of drug substances.Key Responsibilities1. Ensure quality oversight on all QMS documents and systems, to ensure consistency of global standards, harmonization, sharing of best practice and productivity.
3. Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements.
4. Conduct Quality reviews to evaluate if process and deliverables fulfills requirements of quality.
5. Involve in regulatory, customer and internal audits.
6. Ensure system of issuance, retrieval and archival of documents is in place and routinely followed.
7. Ensure registration of Quality Events timely as per the approved procedures.
8. Review of Investigation reports for data furnished for correctness of statements, evidence-based review and ensure no errors in the data and conclusions derived.
9. Review of CAPA for effectiveness and negative impact and ensure closure in time.
10. Involve in Investigation of Out of Specifications and ensure the investigations are timely conducted and root cause analysis is adequately carried out.
11. Assessment of change controls for impact and review of mitigation plans for risk identified, ensure changes are implemented timely and closed.
12. Assessment of Event for Impact, Investigation mechanism and scientific aspects.
13. Trending of Deviations, change controls, CAPA and OOS and assessment for effectiveness of quality procedures for events and propose recommendations based on observations.
14. Making sure that quality related complaints are investigated and resolved.
15. Reviewing and approving procedures, validation protocols and reports.
16. Performing product quality reviews. Evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables,
and to identify strengths and opportunities for improvement.
17. To support the development and delivery of training in quality function.
18. Involve in management review meetings to identify opportunities for continual improvement of Quality Management system.
19. Release/Reject of drug substances.Educational QualificationsRequired Education Qualification: Bsc
Required Experience: 5 - 9 years

Biocon