- Managing All Shift processes in Manufacturing Operations for API-1 to API-2, Shop Floor, Handover, Work allocation, etc.
- Execution of Manufacturing Operation, Safety/GMP Compliance, Housekeeping & Sanitization.
- Resource utilization as per Batch Manufacturing & Equipment Cleaning records.
- Compliance with Safety/GMP norms as per SOPs
- Updating status board, logbook, Batch manufacturing record, Equipment cleaning record, and other production records.
- To ensure the availability of Raw material, packing material, and solvents as per batch manufacturing record for execution of the batch.
- To supervise the activity of lot preparation of raw materials and intermediates as per instructions in batch manufacturing record.
- To perform / verify the calibration of equipment / instruments / Accessories.
- To issue, receive, verify, and store RM, PM, solvents and seeding material.
- To perform return material procedure, disposal procedure for raw material, packing material as per the standard operating procedure.
- To perform and execute operation and cleaning of equipment like reactor, centrifuge, sparkler filter, multi mill, sifter, vacuum tray dryer, and blender, etc. as per BMR and ECR.
- To perform dispensing activity and verification of raw material during batch processing and batch charging as per BMR and SOPs.
- Performing Inprocess sampling during batch processing, sample analysis at plant level (like pH, etc.), and equipment cleaning as mentioned in Batch manufacturing record and Equipment cleaning record.
- To coordinate with the QC department for in-process, intermediate, API, Fresh solvent, recovered solvent testing, result & analysis.
- To perform, verify, and receipt of the additional material (as per requirement).
- To perform a visual inspection of cleaned equipment.
- To report unsafe acts and conditions to superior.
- Handling of chemicals and solvents (like fresh, recovered, recoverable, and spent solvent) by referring MSDS.
- Ensure preventive maintenance of equipment is carried out as per schedule.
- To dispose of the waste as per the procedure.
- To perform process validation, cleaning validation activity as per protocol.
- To perform miscellaneous protocol base activity as per requirement through QMS.
- To fill the all production-related documents as per Good documentation practices SOP.
- To perform/verify packing, repacking & labeling activity as per instruction in BMR, BPR & requirement.
- To report any abnormality or deviation, to shift in-charge or superior.
- To give compliance against audit observations.
- Carry out the qualification of equipment such as Operational Qualification, Performance
- Qualification, and coordination with the engineering department for Installation Qualification.
- To assist the sampling activity of cleaning, in-process, intermediate, and finished product.
- To initiate, verify, and execute work permits as per requirement.
Location: Kurkumbh, Pune
Qualification: Appropriately Qualified
Experience: 6-10 Years
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