Production Manager – Injectable Facility | Immacule Lifesciences | Nalagarh
Roles and Responsibilities:
Note: Experience in CNC/ Autoclave /Filling & Sealing / QMS/ Lyophilizer / Terminal Sterilizer / Tunnel Sterilizer and from USFDA approved Pharmaceutical Industries
- Day-to-day planning, target achievement in the 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 SOPs and master batch packing record.
- Handling batch activities like- Media fill, Scaleup/Engineering, Exhibit, PPQ, and commercial batches.
- Ensure the completion of the batch as per the production plan, and Control daily production output.
- Review and Compliance with executed Batch Record and submit to QA 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
- Optimizing man & machine utilization to achieve pre-set production targets.
- Any other job assignment allocated by the 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, the suggestion of CAPA, preparation review, and compliance of investigation reports.
- Responsible for raising and executing 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 discipline in the departments.
Qualification: B.Pharma, MS/M.Sc(Science) in Chemistry, M.Pharma