Senior Manager Quality Control

🚨 We’re looking for a vigilant Quality Control & Compliance Senior Manager with strong expertise in regulatory systems, laboratory management, and audit readiness. If you excel in implementing SOPs, driving ICH/cGMP compliance, managing QC operations, and ensuring seamless regulatory inspections, this opportunity to elevate quality standards and operational excellence in a high‑impact pharmaceutical environment is for you.

Main Responsibilities:

1. Implementation of Procedure supporting the quality control SOP’S and Corporate SOP’S.
2. Review and approval of specification of RM/FP/STP/SOP. Review and approval of Protocol/Reports.
3. Ensuring and organizing Professional / regulatory training of QC Lab employees.
4. Involving in the OOS and deviations from QC, QA and Production. Ensuring the investigation on OOT & boarder line results.
5. Signing on approved column in data books, laboratory control card and signing on the COA of final material and signing on hard copies as well as approval (release) in LIMS.
6. Implementing quality system with respect to regulatory ICH & CGMP requirement.
7. Handling of customers queries and regulatory inspections. Supporting DMF’S w.r.t required documents from QC.
8. Manpower evaluation in the lab as per Projections and allotment of jobs to team members timely. Monitoring of productivity of people and timeliness of Laboratory activities like releases and schedules.
9. 24 × 7 audit readiness.
10. Budget management of Capital and Revenue w.r.t QC as per the needs
11. Ensuring the Annual maintenance and calibrations for all equipment in the   QC Lab
12. Ensuring software qualification and their CSV
13. Ensuring the environmental, water samples analysis w.r.t chemical and microbiology as per schedules
14. Ensuring all the analysis in laboratory including cleaning w.r.t production planning
15. Gases (utilities) sampling and analysis as per requirement
16. Ensuring standard /chemical reagent management and their qualification based on requirement
17. Ensuring third party operation and their qualification
18. Ensuring the Proper site transfers or method transfer to QC
19. Ensuring method verification and validation based on requirement
20. Facility up gradation w.r.t QC wherever required
21. Supporting Corporate Quality Management as and when required
22. Ensuring the implementation of Pharmacopeias updates.