Biocon - Senior Manager

1. Obtain assessment documents by obtaining from suppliers and service providers.

2. Qualification of new materials from suppliers.

3. Preparation to regulatory audits and confirming the audit dates from suppliers.

4. Review and approval of ASL & ASPL by verification of supplier qualification documents.

5. Co-ordinate with SCM for vendor related activities.

6. Provides information about storage conditions, TSE/BSE clearance to the stakeholders.

7. Coordinate with suppliers to complete the approvals of Quality Agreements.

8. Preparation of all types of agreements in coordination with suppliers.

9. Preparation of Quality agreement and amendments based on the requirement.

10. Support to RA in requesting the supplier documents from WH.

11. Logging the Vendor complaint and contact Vendor for investigation report and followed with appropriate CAPA.

Primary (Primary):

CQA - Mandatory Responsibilities:

1. Responsible to follow basic procedures in the company.

2. Responsible for documentation, Sign. off and filing of individual records

3. Responsible to follow the visitor policy, Hygiene practices when required.

4. Responsible to follow Quality department functional procedures.

5. Ensure to follow the Quality Policy and Data Governance Policy.

6. To ensure Quality and Compliance.

Primary (Primary)

Quality Management System (QMSLTeam Lead

1. Improve / Harmonization and implementation of QMS procedures.

2. Ensure on-time approval/ closure of change controls, CAPA, deviation of CQA.

3. Supports in coordination with CFT's and completion the action items, interim reports, deviation reports, CAPA etc on-time.

4. Ensure all the pre and post implementation action items, effectiveness check are completed on time.

5. Managing lifecycle of Global Quality procedures (Preparation, review, approval, training and implementation).

6. Monitoring of practices against the procedures and ensure all the gaps are identified.

7. Ensure all the documents related to QMS are archived as per the procedure.

8. Approval of Trend analysis for Change controls, Deviations, CAPA, OOS, OOL etc.

9. Review and approval of training modules for QMS procedures and impart training to all the sites.

10. Review and approval of CQA related SOP's/ Forms in OMS

11. Issuance and control of documents.

12. Creation/ Revision of types of documents applicable to CQA in OMS

13. Provide necessary support and expertise to all sites on OMS.

14. Acts as a Trainer and SME to sites with respect to OMS.

15. Review of Global and Executive (BBL) QMR.

16. Review Site QMR for adherence to procedure and improvement opportunities.

17. Review Quality System Performance for all sites and derive improvement opportunities.

18. Review the changes/updates in Regulatory guidelines.

19. Review and approval of Assessment form for the impact on changes to regulatory guidelines.

20. Review and approval of Assessment form for external/internal audit observations.

21. Coordinate and support team actions for regulatory audits.

22. Review and execution of enhancement/improvement projects.

23. Management of External/ Regulatory Inspection (ISO 13485 & CE certifications) & Audit compliance.