Job 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 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 & 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"".
