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.
Work Experience
2 to 5 years of experience