Job Description
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"
