Sun Pharma Hiring QC Executive

Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.

Post : Executive - QC

Job Description
1. Review and approval the QMS e.g OOS ,OOT, Lab event , deviations ,change control ,CAPA etc.
2. Review /Approval the routine analytical raw data of finished products /API /IP/PV/Pkg etc.
3. Assure all time readiness of site for regulatory agency inspections\internal audits and appropriate implementation of corrective actions regarding observations made by the agencies\internal audit teams.
4. Ensuring compliance to regulatory requirements on product, process and release procedures. Ensure release of safe and effective drug products from site as per cGMP Requirement and regulatory commitment.
5. Facilitate internal and regulatory agency audits, ensuring that findings from site audits are understood, assessed and addressed site wide in a comprehensive manner.
6. Monitor industry trends/issues faced internally and identify scope for improving Site quality assurance management and processes.
7. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Performs all work in accordance with all established regulatory and compliance and safety requirements.
8. To ensure the compliance on control and maintenance of Quality Control system this includes daily round and observations.
9. To be a team member in identification of RCA and CAPA.
10. Review and approval of QA of QC and respective department SOP in EDMS Software.

11. To ensure the response provided by QC is adequate and compliance for the observation
Findings in Quality Control.
12. To review and approval of OOS investigation report/Out of trend investigation report/Out of
Calibration report/ Laboratory Event/ Deviation/ Action item/ CAPA.
13. To approve analytical COA & test plan in LIMS.
14. Responsible to review Audit trail of laboratory instruments and software like EWS, Empower, LabX etc.
15. To release/Approval of the RM/PM in SAP HANA and Analytical technology transfer/validation /development etc.
16. Responsible to provide a data of OOS/OOT/Lab Event/FAR/OOC/CAPA/Recall for Quality Council/ R&D Team as applicable.
17. Responsible to provide analytical data for annual quality review as applicable.
18. Responsible for verification of qualification and training record of Laboratory Analysts.
19. Trending of QA observations from raw data review and suggest for improvement.
20. Approval of stability protocol, Method Transfer protocol/report, Method Validation Protocol / report, stability summary report.

21. To review Pharmacopeia – Evaluation and Equivalence Report.
22. To perform the trend analysis of OOS/OOT/Lab Event/QA of QC observation and evaluate the CAPA effectiveness for repetitive Deviation and internal quality observations.
23. To actively participate in cross functional investigation.
24. Review of regulatory query response.
25. To provide technical training with respect laboratory function.
26. Issuance of template/documents /log books etc.
27. Verification of data associated with qualification of laboratory instrument.
28. Verification of data associated with the sample destruction
29. To issue, review, maintain & archive GMP documents for QC lab.
30. Perform the internal audit.
31. Review and approval of Raw material and stability summary sheet report.
32. Lead to present/discuss and define way forward for fast track remediation of open action items related to computerized systems in site Global review meetings.

Additional Information
Educational Qualification : M. Pharmacy / B.Pharma, MSc chemistry
Experience : 10+ years
Location : Halol
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th November 2026