Manager/ Senior Manager- ESQA

Role Summary

Provide quality oversite and governance to ensure compliance with Biocon and health authorities requirement at contract manufacturing organization.

Required Education Qualification:

Required Experience:

Key Responsibilities

1. Supporting and participating in regulatory agency inspections and third-party audits at contract manufacturing organization.

2. Establishing quality performance indicator (QPI) and reporting quality metrics to senior management.

3. Acts as the primary point of contact with third party organizations on all quality related matters and QMS.

4. Ensuring the site for anytime audit readiness.

5. Review and approval batch records and quality control records to release the products into markets.

6. Annual product quality reviews and ensures recommendations are implemented in a timely manner.

7. Reviews and approves stability, process validation and analytical method validation protocols and summary report and performing batch releases.

8. Developing and driving continuous improvement initiatives.

9. Enhancing quality culture and quality maturity through proactive interactions and engagement with team.

10. Develop relationships, negotiating quality issues with CMOs quality leadership team for the enhanced compliance.