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 and supervise 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 with collaboration with R&D. 3.To carry out the defined developmental experiments for yield improvements and process scale up. To execute DSP process for scale up batches of Influenza drug substance. 4.To execute process validation and cleaning validation. 5.Troubleshoot the technical issues in consultation with the Production Head during the shift duties. 6.Ensure strict cGMP compliance and SOP adherence during the unit operations and for the facilities, documentation, training reports and records during manufacturing activities with no deviations. 7.Maintaining manufacturing records and logbook with zero error to comply with regulatory requirements. 8.To carry out in-process analysis during batch operations and monitoring of process-parameters. 9.Schedule and monitor regular maintenance of equipment and facility in coordination with engineering team, ensure timely closure of breakdowns and performance of equipment qualification and calibration activities. 10.Audits – Ensure readiness of facility for internal and external audits and ensure 100% compliance with no major observations. 11.To execute CAPA for compliance of audit observations. 12.Preparation of QMS related documents like change control, deviations, CAPA and investigations. 13.Timely preparation and revision of MMD and SOP’s, LSP. 14.Collaborating with cross functional teams like quality assurance, quality control, engineering, and warehouse for timely manufacturing of drug substance 15.Provide training to new personnel in a specific technical process and support staff in local vernacular language. 16.Ensure strict adherence to EHS norms to ensure safety during manufacturing activities. 17.Ensure the inventory and supply of goods, consumables and material for smooth manufacturing.
