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Centaur Pharma Hiring For Quality Control Department
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 -
- Responsible for overall control of QC department, expertise in QMS, GLP & Compliance, RM, PM, Stability, Audit Compliance, AMV, AMT.
- Good communication skill, having experience in handling team of 100-150 manpower.
- Well versed with current regulatory guidelines, ICH guidelines, 21CFR guidelines.
- Knowledge of QC instruments & handling of trouble shooting of critical Instruments
- Defining departmental employee's roles, responsibilities and authorities.
- To monitor upkeep and compliance of laboratory in regulatory view.
- Maintenance of Good laboratory Practices and compliance at laboratory.
- Review, approval and implementation of standard operating procedures (SOPs), specifications, test methods, Pharmacopoeia updation and other system documentations.
- Handling of Deviation, change controls, OOS, OOT, Lab Error, incidents and failures.
- Ensuring the identity, strength, purity and safety of the drug product through Quality management system
- Approval/rejection of Raw materials, in process, finished product, Stability products and packaging material.
- Budget preparation and support in purchase of instrument, chemicals and other consumables.
- Ensure timely Qualification, calibration, PPM activity and its record, providing necessary documents, guidelines, materials and support to maintain the Quality Control systems.
- Detecting problems related to the QMS and implementing solutions.
- 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.
- Handling of Internal, external, vendor and regulatory audit.
- Planning and Monitoring of testing in AMT, AMV and Trial batch samples
- Responsible for allocation of job, departmental design, QC manpower budget as well as right person at right place.
- Responsible for cost saving, handling of resources efficiently & effectively.
- Handling of regulatory audit its compliance and response activities
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