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Job Location | Hyderabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Sales / BD |
EmploymentType | Full-time |
Dear All,Greeting from Hetero BiopharmaWe have an opening for QA(IPQA-Biologics)Company Name: Hetero Biopharma LtdDepartment: QA(IPQA-Biologics)Designation: Manager/senior Manager Experience: 10 Yrs to 15 Yrs Job Location: Jadcherla (Telangana)Responsibilities:1. Responsible for Monitoring and execution of manufacturing and warehouse IPQA activities. 2. Responsible for Monitoring and Coordination of process validation, Hold time studies, visual inspection, media fill and cleaning validation activities3.Responsible for preparation of IPQA SOPs and review of art works and manufacturing department SOPs.4. Responsible for preparation of Annual Product Review Reports.5. Responsible for compliance to GMP.6. Responsible for review of all manufacturing and warehouse log books.7. Responsible for review of master and executed BFR s, BPR s and DR s.8. Responsible for approval of batch release report for drug product.9. Responsible for conducting weekly inspection for manufacturing and Warehouse areas.10. Responsible for sampling during manufacturing and packing stages as per applicable SOP s.11. Responsible for performing in process checks during manufacturing and packing operations as per respective SOP s. Interested candidates please share profiles to edukondalu.m@heterodrugs.com ,
Keyskills :
packingartoperationscheckssopmusic makingcleaning validationbpripqavalidationvisual inspectioncomplianceprofilescontinuous improvement facilitationmonitoringinspectionprocess validationbatch releasesamplingwarehouse