Description

Principal task and Responsibilities: -Supervising & performing production activities of Streptokinase Drug Substance, Erythropoietin Drug Substance, Anticoagulant Drug Substance and Drug product, GCSF Drug Substance. -Coordination with Injection department for formulation of STPase Injection, Cadicrit Injection, FILCAD Injection as per the laid standards. Responsibilities: -Ensure strict cGMP compliance during the unit operations and for the facilities, documentation, training reports and records for Drug Substance Streptokinase, Erythropoietin Drug Substance, GCSF. -Planning, supervising & performing production activities of Streptokinase Drug Substance, Erythropoietin Drug Substance, GCSF Drug Substance. -Formulation of STPase Injection, Cadicrit Injection, FILCAD Injection as per the laid standards -Maintaining records to comply with regulatory requirements. -Monitoring manufacturing processes and in process results of different unit 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 section Head during the shift duties.



-Participate in audits and investigations to recommend solutions and justifications and resolve problems. -Culture propagation and preservation for streptococcus strain, CHO Cells, E. coli culture. -Operation of all the equipment required for upstream and downstream process of Streptokinase Drug Substance, Erythropoietin Drug Substance, GCSF Drug Substance. -To carry out the defined developmental experiments for yield improvements and process up gradation. -Provide training to current 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 & ordering of laboratory supplies for smooth functioning of facility. -coofdinâting 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"".

📌 Technical Supervisor (India)
🏢 Cadila Pharmaceuticals
📍 India