Executive

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 Substanc? \-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, Deviation, Change control, Online documentation, BMR Fill up and review \-Facility management and Ordering of laboratory supplies \-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