Senior Technical Supervisor

Cadila Pharmaceuticals Limited

0 years

0 Lacs

Dholka Gujarat India

Posted:3 days ago| Platform:

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Skills Required

compliance documentation training reports monitoring manufacturing technology audits resolve preservation analysis testing management schedule maintenance coordination engineering

Work Mode

On-site

Job Type

Full Time

Job Description

Ensure strict cGMP compliance during the unit operations and for the facilities, documentation,training reports and records for Biologics
Performing the production activities of Biosimilar Drug Substance
Operation of all the equipment required for upstream and downstream process of Biosimilar Drug Substance
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
Technology Transfer activities
Readiness of facility for internal and external inspections
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
Culture propagation and preservation for Clostridium strain.
Provide training to new personnel in a specific technical process
To carry out the In-process analysis during the batch operation and Testing of cell bank
QMS related activities,Change control, Deviations, Online documentation,BMR Fill up and review
Facility management & ordering of laboratory supplies for smooth functioning of facility
Coordinating with different departments for timely manufacturing of biologics and with external agency for shipment of sample and discard of waste materials
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

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