1. Managing the entire QA and QC activities in the plant.
2. Monitoring, Documentation and implementation of process development.3. Making sure that there is satiability data to support retest or expiry dates and storage conditions on APIs and /or intermediates where appropriate; and performing product quality reviews.4. Reviewing completed batch production and laboratory control records of critical process steps before release of the API intermediated for distribution 5. Making sure that critical deviations are investigated and resolved.6. Approving all specifications and master production instructions, Test methods, Qualifications. 7. Approving all procedures impacting the quality of intermediates or APIs.8. Making sure that quality related complaints are investigated and resolved.9. Making sure that materials are appropriately tested and the results are reported.10. Ensuring Technology Transfer from Pilot Plant Level to Plant Level implementation.11. Ensure the preparation of DMF and other related information at all the Units.12. Ensuring Quality management system is followed at the site.13. Responsible for all the Internal and External Quality Audit and EHS Aspects.14. Handling regulatory details under guidance of Director(Works)15. Approving intermediate and API contract manufacturers.16. Approving changes that potentially impact intermediate or API quality.17. Ensuring GMP training is providing to all the employees in the site.18. Ensuring quality culture in the organization on QMS EMS.

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Quality Assurance Manager