Job Description

1. Readiness of facility for internal and external inspections. 2. Documents issuance and timely submission to QA. 3. Preparation of documents as per regulatory requirement like MMD, SOPs and other technical documents. 4. Environmental monitoring (Non-viable particle counting) of manufacturing area. 5. Independently working in all shifts. 6. Troubleshoot the technical issues in consultation with the Production Head during the shift duties. 7. Preparation and maintenance of WCB, MVS and WVS for upstream technicians 8. Operation of all the equipment required for upstream process of Drug Substance for upstream technicians 9. QMS related activities like change control, deviations, CAPA, incident management, risk management etc. 10. To carry out the In-process analysis during the batch operation wherever applicable 11. Coordinating with different departments for timely manufacturing of drug substance 12. Efficiently execute the production schedule without deviations 13. Monitor and regular maintenance of equipment and facility in coordination with engineering team". 14. Upstream operations for DS manufacturing of Influenza and rabies vaccine 15. Management of cell factory

Skills Required