Senior Manager Production Sterile

3 days ago


himachal pradesh, India Immacule Lifesciences Full time
Responsibilities -
- Day to day planning, target achieving in monthly production plan
- Proper coordination and communication with other departments for better execution of processes
- Prepare Machine URS / DQ and execute the qualification of IQ/OQ/PQ
- Preparation of SOP's and master batch packing record
- Handling of batch activity like- Media fill, Scaleup/Engineering, Exhibit, PPQ and commercial batches
- Ensure the completion of batch as per the production plan, Control on daily production output
- Review and Compliance of executed Batch Record and submit to QA in within time
- Immediate information to superiors in case of any anomalies found in the process
- Overseeing production related tasks including planning, control and troubleshooting
- Setting up production targets and achieving the same within time and cost parameters
- Optimising man & machine utilization to achieve pre-set production targets
- Any other job assignment allocated by site head
- Documents preparation and changes in existing documents as per USFDA and cGMP requirements
- Responsible for investigation of non-conformities, identification of root cause, suggestion of CAPA, preparation review and compliance of investigation reports
- Responsible for raising and execution of change control and CAPA and its implementation through eQMS software
- Responsible for preparation and review of Risk assessment related to process and product attributes
- Maintained the discipline in the departments

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