DGM / GM - Quality (DS Biologics)

USV; Navi Mumbai; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

USV in Navi Mumbai seeks a senior Quality Leader to oversee QMS, Quality Control and Quality Assurance functions across the site. You will ensure products meet approved specs, drive CAPA through root cause analysis and support regulatory readiness.

Role involves leading SAP and LIMS, coordinating audits, and guiding training and personnel development to uphold USV quality policy and EHS standards.

Qualifications

• Experience in Quality Management System (QMS) and regulatory compliance.
• Capable of driving CAPA through root cause analysis and effective investigations.
• Familiar with SAP and LIMS processes and documentation.

Responsibilities

• Oversee QMS, Quality Control and Quality Assurance activities.
• Ensure products meet approved specs and batch records.
• Lead audits, regulatory readiness and incident investigations.

Skills

Quality management

Regulatory compliance

Tools

SAP

LIMS

Job description

A) Quality Management System / Quality Control / Quality Assurance :

1. Overall responsible for Quality Control, Quality Assurance and Quality Management system.

2. Verify and monitor all the activities Quality Control and Quality Assurance department and ensure smooth functioning of the department.

3. Ensure that the products manufactured at the site are meeting approved standard specification and manufactured with respect to approved batch records.

4. Ensure effective implementation of USV Quality Policy and EHS policy at site.

5. Ensure CAPA’s identified through root cause analysis are implemented.

6. Ensure market complaint, out of trend, OOS and incidents investigation done effectively and timely approved.

7. Decision making while batch disposition of rejected batch /material.

8. To elevate critical information or issues related safety, identity, strength, purity and quality of drug product to Head CQA.

9. To present the quality data and critical quality issues during Site Quality Review Committee and Corporate Quality Review Committee meeting.

10. Ensure new product launches (Exhibit and Commercial) are supported for timely launch in market.

11. Ensure stability study conducted as per approved protocols and testing is executed as per defined time intervals/period defined in procedures.

12. Ensure appropriate facilities and resources are available for smooth functioning of Quality function.

13. Ensure smooth functioning of SAP and LIMS.

14. Ensure goal setting and performance appraisal of team.

15. To recruit and retain technical staff in Quality function.

16. To propose and review revenue and capital budget for Quality function.

17. Review and approval of QMS (Deviations, incidents, OOS, OOT, Change controls).

18. Approval of QMS related activities.

19. To select members for Site Data Integrity champions team.

20. Facility up gradation and Quality system up gradation.

21. Approval of all CSV related documents, Qualification documents and URS.

22. Review and approval of process validation, cleaning validation protocols and reports.

23. Ensure support to regulatory function in timely submission of documents.

B) Documentation :

1. Ensure timely preparation, approval and effective implementation of Site Standard Operating Procedures.

2. Approval of Master Formula for Drug Substance.

3. Ensure timely preparation, approval and effective implementation of Quality function documents as per SOP.

4. Ensure timely Annual Product Quality Review and necessary corrective action.

5. Ensure timely qualification and training of personnel.

6. Review and Signing of Confirmation of Compliance (CoC).

7. Review and approval of Quality Risk Management study for systems, equipment, facility, utilities, material, pharmaceutical process, new API introduction in 3.

C) Audit and Compliance:

1. Ensure all time readiness of site for regulatory inspections, customer audits and Corporate Quality audits.

2. Participation in Self audits and compliance.

3. To conduct Vendor Audit and Contract Laboratories Audit as per requirement.

4. Response to audit observations in consultation with all stakeholders as per the timeline mentioned in the report.

5. Act as Inspection Lead (Escort) in regulatory inspections.

6. Handling of external audits and co-ordination of compliance response to regulatory observations.

D) Market Complaint, Recall and Returned Products :

1. To aid in the investigation of customer complaint as well as and implementation of the suggested preventive actions.

2. Review & approval of the customer complaint investigation report.

3. Ensure timely support of USV affiliates from the site in filed alerts, recalls and product returns.

4. Approval of the preliminary report for returned goods.

E) Training :

1. To provide training related to cGMP and quality Systems or SOP’S.

2. On Job training for Quality Control and Quality Assurance personnel.

3. To provide cGMP training with respect to USV quality policy and regular guidelines.

F) People Development :

1. Provide functional and technical guidance to the team through on the job coaching and support them in capability development.

2. Team motivation and upliftment.

3. Keep self and team updated to developments and advances in his field of work.