To perform plant operations and other assigned tasks with strict adherence to approved procedures. 2. Responsible for understanding of all the process parameters and process steps as written in BMR. 3. Responsible for ensuring following points before batch charging Cross checking weights of raw materials. Checking of all the instrumentation on plant equipment for proper functioning and calibration before starting the batch. Checking and confirming all the production accessories such as scoop, sampling bottles, labels, cleanroom garments are available and in cleaned condition. 4. Responsible for sampling of in process, intermediates, finished products as and when required. 5. Responsible for maintaining proper housekeeping and cleaning in general production areas and clean room 6. SAP management: - PP, WM & MM module. 7. Preparation of documents for upcoming products from R&D and site transfer: - Process Mapping, MFR, BMR, ECR, Block Diagram, Process flow diagram, Tech transfer protocol, Process validation protocol, cleaning validation protocol. Technology Transfer of products from lab scale to Production scale. Successful completion of Trail Batch & Validation Bathes of new products. 8. Preparation & execution of qualification documents: - URS, DQ, IQ, OQ & PQ. 9. Documentation: - Change Control, Deviations, OOS, RCI and CAPA handling in Track wise. Review of filled BMR and submission to QA. Preparation of SOP’s and implementation. 10. To achieve Production Target: - Manpower shift planning. Monitoring of shop floor activities. Imparting training to shop floor team for new product. Monitoring of Production activity as per cGMP guidelines. RM usage as per standard range of consumption co-efficient. Availability of consumables required for Production. Co-ordination with supporting departments like Warehouse, QA, QC, EHS, Engineering & admin. 11. Operation &am
