Principal task and Responsibilities: -Supervising & performing production activities of Streptokinase Drug Substance -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. -Supervising & performing production activities of Botulinum Drug Substance Responsibilities: -Ensure strict cGMP compliance during the unit operations and for the facilities, documentation, training reports and records for Streptokinase and Botulinum -Maintaining records to comply with regulatory requirements. -Monitoring manufacturing processes and in process results of different unit operation Preparation and review of documents as per regulatory requirement like MMD, SOPs and other technical documents -Readiness of facility for internal and external inspections -Culture propagation and preservation for streptococcus strain -Culture propagation and preservation for Clostridium strain -Operation of all the equipment required for upstream and downstream process of Streptokinase Drug Substance and Botulinum Drug Substance -To carry out the defined developmental experiments for yield improvements and process up gradation -Provide training to new personnel in a specific technical process -To carry out the In-process analysis during the batch operation QMS related activities, Change control, Deviations, Online documentation, BMR Fill up and review -Facility management -Coordinating with different departments for timely manufacturing of biologics -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"
