Role & responsibilities

1. Responsible for Audit of regulatory loan license units/ third party manufacturing location.

2. Responsible for Audit of Raw material / excipient/ packaging material vendor.

3. Responsible for compliance verification of loan license units/ third party
4. To prepare schedule and ensure execution of periodic LL/TP Audits for Quality

5. Batch release for both TP/LL as & when required.

6. Conduct CAPA verification activities at manufacturing sites for Investigation

7. Joint Analysis and its data verification and upkeep of the records pertaining to Joint analysis.

8. Review of analytical documents related to product transfer/Routine products/ Stability.

9. Products evaluation of Export market at respective site

10. Responsible for Review and Evaluation of Change Controls related to Loan License manufacturing

11. Third party product release in SAP system after COA and technical documentation review.

12.



BOM Verification and coordination with stakeholders and sites for the requirements.

13. Support for Market and FDA complaint handling pertaining to LL/TP, follow up till the Investigation conclusion and closure of complaint.

14. Trending of the market complaint as and when required.

Preferred candidate profile

- Hands-on experience in auditing Loan License and Third-Party manufacturing facilities.

- Sound knowledge of cGMP, Schedule M, WHO-GMP, FDA, MHRA, EU GMP, and other regulatory requirements.

- Experience in batch release, investigation management, CAPA verification, and change control review.

- Proficiency in SAP and quality management systems.

- Solid analytical, communication, and stakeholder management skills.

- Willingness to travel for audits and site compliance activities.

📌 Executive Role For Regulatory CMO, CQA (Navi Mumbai)
🏢 Alkem Laboratories
📍 Navi Mumbai