Associate

Lupin; Chhatrapati Sambhajinagar District; On-site; INR 320,000 - 520,000; Full time

Job summary

Lupin in India is seeking a production operator to work in our GMP-compliant manufacturing facility in Maharashtra. You will perform manufacturing and packaging steps under supervision, ensuring adherence to BMRs and SOPs, and maintaining cleanliness and safety in the production area.

The role requires strict attention to cGMP, EH&S, and quality controls, with on-the-job training and ongoing assessments. You will record results, report deviations, and support continuous improvement while

Responsibilities

• Comply with all cGMP, GxP and EH&S requirements.
• Complete training on SOPs and understand activities before starting tasks.
• Follow SOPs; report deviations to supervisor/QA.
• Report quality concerns or improvement suggestions to supervisors.
• Manufacture/processing of batches under supervision as per BMR.
• Handle raw materials, bulk, semi-finished and finished goods.
• Operate, wash and clean equipment and accessories per SOP.
• Maintain area and machines per GMP standards.
• Support Quality Management Systems and report discrepancies.
• Receive RM/PM from Warehouse and keep areas clean.
• Record online in respective documents per SOP/BMR.
• Maintain personal hygiene before production area and follow HR rules.
• Perform in-process checks per BMR and record results.
• Attend cGMP/On Job/Functional training as per planner.

Job description

• Comply with all cGMP, GxP and any other applicable regulatory requirement, including EH&S requirements.
• Complete training on relevant SOPs and develop an understanding of the activities to be conducted prior to undertaking any task.
• Conduct all tasks/activities as per the applicable SOPs. Report any difficulty or deviation in following the procedure/instruction to immediate supervisor/managers.
• Report any quality concern or suggestion for improvement to supervisors/ managers.
• Manufacturing / processing of batches of assigned products under supervision as per instructions given in the BMR.
• Handling and movement of raw material, bulk, semi-finished and finished goods.
• Operation, washing and cleaning of equipment’s and accessories used in related production activities as per respective SOP.
• Up-keeping area and machines as per GMP requirements.
• To Support Quality Management Systems and to report any discrepancy, abnormity, non-conformance or any incidence observed to the Department Head and QA Head.
• Receipt of RM and PM from Warehouse and ensuring overall cleanliness of areas.
• Doing operations as per the SOPs and BMR with online recording in respective documents as applicable.
• To ensure self-hygiene before entering in the production area and follow all the other rules & regulation set by HR department.
• Performing in-process checks as per respective BMR and recording of results of in respective documents as applicable.
• To fulfil the training need as per current needs with respect to cGMP, Job, safety, health & Hygiene by attending the training programmes.
• Cost effectiveness in production operation by controlling overtime, revenue expenses and achieving standard yield.
• Critically monitoring of the environmental conditions with a view to meet the standards mentioned in BMR and SOP.
• Ensure calibration and preventive maintenance of manufacturing equipment and instruments as per approved schedule and the results of same meeting the standards.
• To perform line clearance activity during batch to batch and product to product change over and ensure the compliance as per SOP.
• Issuance, retrieval and destruction of dies and punches, product dedicated bags and sieves, silicon sleeves, pipes, hose pipes and screens.
• To ensure the audit compliance.
• Trouble-shooting: To attend the problems of machine and process as and when necessary.
• Any other assignment allocated by production Head.
• To attend required cGMP/ On Job /Functional training activities as per planner.