Description

Principal task and Responsibilities: 1. DSP operations for Drug Substance Manufacturing 2. QMS, GMP compliance 3. Managing manufacturing facility 4. Inventory Management. 5. Cross functional collaboration Responsibilities: 1. To execute DSP operations for drug substance manufacturing of Seasonal Influenza Vaccine (Cadiflu tetra) and Rabies Vaccine (Thrabis). 2. Preparation of CT material -to execute DS batches of Clinical Trials in collaboration with R&D; team. 3. Scale up of DS manufacturing -to execute DSP process for scale up batches of Influenza drug substance. 4.Troubleshooting of DSP operations during drug substance manufacturing. 5. To carry out in-process analysis during batch operations and monitoring of process-parameters. 6. Timely completion of batch records and logbooks with zero error. 7. To execute media fill activities. 8. To perform and oversee the qualification, calibration and annual maintenance of manufacturing equipment like purification systems, filtration systems, filtration isolator etc. 9.



To execute process validation and cleaning validation. 10. To ensure GMP compliance and SOP adherence during drug substance manufacturing. 11.Audits - Prepare for internal and external audits and ensure 100% compliance with no major observations. 12, To execute CAPA for compliance of audit observations. 13. Timely preparation and revision of MMD and SOP's. 14. Collaborating with cross functional teams like quality assurance, quality control, engineering, and warehouse for timely manufacturing of drug substance. 15. To work with engineering team to manufacturing facility management and timely closure of breakdowns. 16. To train current team members and support staff. 17. Ensure strict adherence to EHS norms to ensure safety during manufacturing activities. 18. Ensure the inventory of goods, consumables and material for smooth manufacturing.

📌 Executive (India)
🏢 Cadila Pharmaceuticals
📍 India