JOB RESPONSIBILITIES Ensure strict cGMP compliance during the unit operations and for the facilities, documentation, training reports and records during DS manufacturing for Vaccine Planning, supervising & performing production activities of Drug Substance Maintaining manufacturing records to comply with regulatory requirements. Monitoring manufacturing processes and in process results of different unit operation wherever applicable. Preparation and review of documents as per regulatory requirement like MMD, SOPs and other technical documents Readiness of facility for internal and external inspections Troubleshoot the technical issues in consultation with the Production Head during the shift duties. Participate in audits and investigations to recommend solutions and justifications and resolve problems Preparation and maintenance of WCB, MVS and WVS for upstream technicians Operation of all the equipment required for upstream process of Drug Substance for upstream technicians Operation of all the equipment required for downstream process of Drug Substance for downstream technicians To carry out the defined developmental experiments for yield improvements and process scale up Provide training to new personnel in a specific technical process To carry out the In-process analysis during the batch opération wherever applicable QMS related activities like change control, deviations, CAPA, incident management, risk management etc. Facility management & ordering of laboratory supplies for smooth functioning of facility Coordinating with different departments for timely manufacturing of drug substance Ensure safe and efficient operation of Production equipment following safety procedure in order to protect the safety of themselves and their colleagues Efficiently execute the production schedule without deviations Schedule and monitor regular maintenance of equipment and facility in coordination with engineering team" Technical Person for review and approval of batch manufacturing record
