Sr. Manager - Quality Control

Detailed Job Description

1. Ensures that the proper monitoring and the maintenance of department premises and equipment are done properly and ensures that the monitoring of the calibration program of equipment is done.
2. To ensure the quality of raw materials, packaging materials and finished products are compliant with the approved specifications and GMP/GLP.
3. Manage, plan and direct the Quality Control Chemical and Microbial laboratories to ensure lab testing provide the highest quality analytical support for manufacturing while ensuring compliance with protocols, GMP and safety regulation.
4. Monitors compliance with the requirements of approved procedures.
5. Overall planning of activities in all Quality Control Chemical and Microbiology laboratories for analysis of Finished products, Validation samples, stability samples, Raw Material, Packaging Material, water analysis and Sampling of (RM/PM/Water).
6. Execute and manage the commercial (on going stability and commitment) programmes and maintain compliance with ongoing and new regulatory requirements.
7. Day to day tracking for KPIs (release of the finished products and raw materials) and performance with the team.
8. Review/approve SOPs and work instructions.
9. Complete corrective and preventive actions assigned by investigations or audit observations.
10. Review and approve protocols and reports such as method validation, method transfer, process validation and stability.
11. Training of newly joined staff with overall supervision on training activities for his staff.
12. Adherence and timely completion of Quality systems processes OOS, OOT & investigations in line with current SOPs.
13. Execute and approve all laboratory investigations.
14. Ensures Date Integrity implementation and follow up as per Regulations and Company Protocol.
15. Good practice in evaluating employee performances, HR and talent development procedures.
16. Updating the procedures & practices as per current regulatory & cGMP requirements.
17. Involve in internal and external audits and close all the observations appropriately.
18. Supporting the cross functional departments to achieve the goals / targets of the company.
19. Handling of Quality management system like Change controls, Deviations, CAPAs, Self-inspection actions through Ample logic system.
20. To approve all Chemical and Microbiological analysis reports and analytical batch records.
21. To prepare and involve in Capex and Opex requirements for QC.
22. To prepare and involve in Budget requirements of QC.

Qualification/Functional Knowledge

1. Bachelor’s degree in pharmaceutical Science (Pharmacist); Master’s degree preferred.
2. Minimum 15 years of experience in the QC Department.
3. Proficient with computer software application (MS word, MS excel, SAP).