Source description
About the role
Responsible to understand the new process/ tech transfer during the walk through and ensuring the facility accordingly. Responsible to Plan and completing line modification activities as per Execution plan (based on the process requirement). Responsible to raise the change control for site initiation for new Product/ Stage/ Campaign. Accordingly arranging the other documents to execute batch in the plant like. Tech pack, Risk assessment, PSSR, PID etc. Responsible for coordinating with other departments like Warehouse, Engineering, QC, Process engineering, PR&D, HSE & QA to complete start up activities as per the time line. Review process with respect to quality, safety, yield, and waste management, availability of utility source and accessories. Collecting more details from PE & PR&D to execute the batch smoothly. During initiation of new product/ stage or change in process, training shall be imparted to concern subordinates and production team. Responsible to track the batch status w.r.t quality, yield, cycle time according to dispatch time line by co-ordination with production team. Verifying data with respect to critical parameters, purity and yield along with batch cycle time of previous batches before executing new campaign / batches. Responsible to report the deviations/ observations /abnormalities immediately to higher officer & Concern persons. Responsible to complete the investigation (Product deviation & OOS) w.r.t process. Responsible in technical troubleshooting the problem arise during process execution. Responsible for ensuring safety practices & instruct to subordinates for the same. Responsible to ensure the RM approved stock availability in advance for batch charging to meet dispatch target. Responsible to assigning job and monitoring subordinate persons activities.
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