16 Aug
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Cadila Pharmaceuticals
|
Dholka
16 Aug
Cadila Pharmaceuticals
Dholka
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. -coo
📌 Technical Supervisor (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka