Associate

Lupin; Chhatrapati Sambhajinagar District; On-site; INR 300,000 - 550,000; Full time

Job summary

Lupin in India is seeking a disciplined production associate to support GMP-compliant manufacturing. You will follow cGMP/GxP standards, complete SOP trainings, and perform assigned tasks with proper documentation.

Maintain cleanliness, monitor environmental conditions, and participate in equipment calibration and maintenance as per SOPs. Responsibilities include packing, material handling, in-process checks, QA reporting, and incident logging.

Qualifications

• Comply with cGMP, GxP and any other applicable regulatory requirements including EH&S requirements.
• Complete training on SOPs and develop understanding of activities before tasks.
• Conduct activities per SOPs and report deviations to supervisor.

Responsibilities

• Packing and documentation of assigned products per BPR, SOP and cGMP.
• Handle movement of bulk, packing material, semi-finished and finished goods per SOP.
• Maintain Overall Equipment Effectiveness (OEE)/Productivity.
• Keep area and machines clean per GMP requirements.
• Operate, wash and clean equipment and accessories as per SOP.
• Monitor differential pressure, temperature and humidity as per SOP.
• Ensure calibration and preventive maintenance of equipment as per schedule.
• Perform in-process checks and record results in BPR.
• Receipt, issuance, retrieval, maintenance and disposal of change parts.
• Attend cGMP/On job/Functional training as per planner.
• Practice proper self-hygiene before entering production area.
• Initiate and review material requisitions, returns and packing material requests.
• Maintain inventory of operating supplies and control manpower usage.
• Support Quality Management System and report discrepancies or incidents to department head.
• Handle Omnidoc, Data Acquisition System (DAS).
• Check strip/blister foil proof with batch packing records and retain proof materials.
• Attend machine troubleshooting and fault finding including blister inspection system and inkjet coding.

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.
• Packing and documentation of assigned products as per instruction given in the BPR, SOP and cGMP.
• Handling the movement of bulk, packing material, semi-finished and finished goods as per SOP.
• Maintaining Overall equipment efficiency (OEE)/Productivity.
• To up keep cleanliness of area and machine as per GMP requirement.
• Operation, washing and cleaning of equipment and accessories used in related production activities as per SOP.
• Monitoring and recording of differential pressure, temperature & relative humidity as per SOP.
• Ensure calibration and preventive maintenance of equipment and instrument as per approved schedule and the results of same meeting the standards.
• Performing in-process checks as per respective BPR and recording of results of in process checks in BPR.
• Receipt, issuance, retrieval, maintenance and disposal of change parts.
• Area and Equipment Usage documented as per SOP.
• To attend the required cGMP/On job/Functional training activities as per planner.
• To ensure proper self – hygiene before entering in the production area and follow all the rules and regulation set by HR department.
• To initiate and review the request like additional material requisition, material return note, packing material carry forward Stereo request and screen request etc.
• To ensure the effective control on usage of manpower, machine and material in the department and maintain proper inventory of operating supplies in the department.
• To support Quality Management system and to report any discrepancy, abnormality, non –conformance or any incidence observed to the department head.
• Handling of Omnidoc, Data Acquisition system (DAS).
• Checking of strip/blister foil proof with batch packing record and also retention of all required packing material proof with batch packing record for packing section.
• To attend the trouble shooting of machine.
• Trouble shooting: Handling, ensuring, verifying and trouble shooting of software like, Blister inspection system, inkjet coding.
• Any additional responsibility delegated by department head.