Centaur Pharma Hiring For Quality Control Dept
Designation- Asst. General Manager/Dy. General Manager - Quality Control
Education- B. Pharm / M. Pharm/M.Sc./Ph.D
Work Experience-18-25 Years
Exposure- QMS, GLP & Compliance, RM, PM, Stability, Audit Compliance.
Team Handling- More than 100-150 persons
Location- Hinjawadi, Pune.
Job Description-
1. Responsible for overall control of QC department, expertise in QMS, GLP & Compliance, RM, PM, Stability, Audit Compliance, AMV, AMT.
2. Good communication skill, having experience in handling team of 100-150 manpower.
3. Well versed with current regulatory guidelines, ICH guidelines, 21CFR guidelines.
4. Knowledge of QC instruments & handling of trouble shooting of critical Instruments
5. Defining departmental employee's roles, responsibilities and authorities.
6. To monitor upkeep and compliance of laboratory in regulatory view.
7. Maintenance of Good laboratory Practices and compliance at laboratory.
8. Review, approval and implementation of standard operating procedures (SOPs), specifications, test methods, Pharmacopoeia updation and other system documentations.
9. Handling of Deviation, change controls, OOS, OOT, Lab Error, incidents and failures.
10. Ensuring the identity, strength, purity and safety of the drug product through Quality management system
11. Approval/rejection of Raw materials, in process, finished product, Stability products and packaging material.
12. Budget preparation and support in purchase of instrument, chemicals and other consumables.
13. Ensure timely Qualification, calibration, PPM activity and its record, providing necessary documents, guidelines, materials and support to maintain the Quality Control systems.
14. Detecting problems related to the QMS and implementing solutions.
15. Allocation of work, roles, responsibility and authorities of RM, In-process, Finished product, Stability and Packaging material. Providing necessary support for the development of employee of QC department.
16. Handling of Internal, external, vendor and regulatory audit.
17. Planning and Monitoring of testing in AMT, AMV and Trial batch samples
18. Responsible for allocation of job, departmental design, QC manpower budget as well as right person at right place.
19. Responsible for cost saving, handling of resources efficiently & effectively.
20. Handling of regulatory audit its compliance and response activities
Please send your resume to
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Centaur Pharma Hiring For Quality Control Dept |
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