Job Description

Department DetailsRole Summary1. To ensure an effective global quality system is in place at B3 (Site 2), adequately resourced and the roles, responsibilities and authorities are defined, communicated, and implemented throughout the organization.
2. Should ensure effectiveness of the quality management system and cGMP compliance.
3. Involvement in management review meetings to identify opportunities for continual improvement of product, processes, and system.
4. Ensure Quality oversight in Manufacturing and QC, to ensure consistency of global standards, harmonization, sharing of best practice and productivity.
5. Develop and motivate team.
6. Releasing or rejecting all Drug Substance. Releasing or rejecting intermediates for use outside the control of the manufacturing company; interact with manufacturing teams, making sure products are getting released on time and with compliance.
7. Establishing a system to release or reject raw materials, intermediates, packaging, and labelling materials;
8. Reviewing completed batch production and laboratory control records of critical process steps before release of the Drug Substance; Review of audit trails of instruments and ensure events generated are authorized.
9. Making sure that critical deviations are investigated and resolved; assessment of deviations for Impact, Investigation mechanism and root cause analysis for logical and scientific aspects.
10. Involve in Investigation of out of specifications (OOS) and ensure the investigations are timely conducted and root cause analysis is adequately carried out of change controls for impact and review of mitigation plans for risk identified, ensure changes are implemented timely and closed.
11. Approving all specifications and master production instructions.
12. Approving all procedures impacting the quality of intermediates or Drug Substance; Review of test procedures in accordance with Method validation reports and ensure procedures written are clear without ambiguity.
13. Approving changes that potentially impact intermediate or Drug Substance quality, assessment product, processes, and system.
14. Reviewing and approving validation protocol sand reports;
15. Making sure that quality related complaints are investigated and resolved;
16. Making sure that effective systems are used for maintaining and calibrating critical equipment;
17. Making sure that materials are appropriately tested, and the results are reported;
18. Making sure that there is stability data to support retest or expiry dates and storage conditions on Drug Substance and/or intermediates where appropriate; and
19. 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.
20. Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements.Key Responsibilities1. To ensure an effective global quality system is in place at B3 (Site 2), adequately resourced and the roles, responsibilities and authorities are defined, communicated, and implemented throughout the organization.
2. Should ensure effectiveness of the quality management system and cGMP compliance.
3. Involvement in management review meetings to identify opportunities for continual improvement of product, processes, and system.
4. Ensure Quality oversight in Manufacturing and QC, to ensure consistency of global standards, harmonization, sharing of best practice and productivity.
5. Develop and motivate team.
6. Releasing or rejecting all Drug Substance. Releasing or rejecting intermediates for use outside the control of the manufacturing company; interact with manufacturing teams, making sure products are getting released on time and with compliance.
7. Establishing a system to release or reject raw materials, intermediates, packaging, and labelling materials;
8. Reviewing completed batch production and laboratory control records of critical process steps before release of the Drug Substance; Review of audit trails of instruments and ensure events generated are authorized.
9. Making sure that critical deviations are investigated and resolved; assessment of deviations for Impact, Investigation mechanism and root cause analysis for logical and scientific aspects.
10. Involve in Investigation of out of specifications (OOS) and ensure the investigations are timely conducted and root cause analysis is adequately carried out of change controls for impact and review of mitigation plans for risk identified, ensure changes are implemented timely and closed.
11. Approving all specifications and master production instructions.
12. Approving all procedures impacting the quality of intermediates or Drug Substance; Review of test procedures in accordance with Method validation reports and ensure procedures written are clear without ambiguity.
13. Approving changes that potentially impact intermediate or Drug Substance quality, assessment product, processes, and system.
14. Reviewing and approving validation protocol sand reports;
15. Making sure that quality related complaints are investigated and resolved;
16. Making sure that effective systems are used for maintaining and calibrating critical equipment;
17. Making sure that materials are appropriately tested, and the results are reported;
18. Making sure that there is stability data to support retest or expiry dates and storage conditions on Drug Substance and/or intermediates where appropriate; and
19. 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.
20. Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements.Educational QualificationsRequired Education Qualification: Msc
Required Experience: 12 - 18 years

Biocon