- To manage day to day activities of downstream operations and activities to be performed as per laid down procedures, which are complying with current cGMP norms.
- Scheduling of the downstream batches
- Reduction of operational cost by evaluating current process requirements, evaluating process, evaluating alternate vendor development
- Analyses of repetitive failure and to provide solution/ develop procedures to bring repetitive deviations under control.
- Review of equipment performance over a period of time and proactively to take action before failure happens.
- Assure that Preventive maintenance, calibration and validation activities are carried out within defined frequency and batches are planned without deviating timelines.
- Ensure the availability of Raw material and Packing material at all times in synchronization with business plans.
- To ensure that downstream facility and documentation is always in a state audit readiness.
- Review of downstream activities which can become potential data integrity issue and laid down procedure / simplify activities for ease to record activities.
- Review of downstream documents record as per technicality and following procedure/ compliance laid down by site.
- Review the deviations, change controls, CAPA and other quality management system.
- Review of MFR, BMR, SOPs, Protocols, reports and other process related documents.
- Assure EHS polices are followed in compliance to current norms in the manufacturing area.
- To monitor performance and guide team member to have smooth flow of working for day-to-day activities.
- Co-ordination with stake holders-QC, QA, Engineering, Supply Chain Management, Purchase, Safety Department etc.
- Work in close coordination with R and D for taking development batches / current projects.
📌 Sr Manager - Production (Downstream) (Maharashtra)
🏢 USV
📍 Maharashtra
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