Officer

Job Description

• Comply with all cGMP, GxP, and any other applicable regulatory requirements, 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.
• Daily planning, job allocation of departmental activities to fulfill the market requirement and commitment.
• Monitoring of IMS, Blister, Strip, Bulk, powder, and batch split-up activity.
• Responsible for shipper labeling as per EMO & all the transactions in SAP for finished products.
• Packing and documentation of assigned products as per instruction given in the BPR, SOP, and cGMP.
• Ensuring the movement of bulk, packing material, semi-finished, and finished goods as per SOP.
• Updating and monitoring of Overall Equipment Efficiency (OEE).
• To upkeep 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.
• Performing in-process checks as per respective BPR and recording of results of in-process checks in BPR.
• Monitoring of differential pressure, temperature, and relative humidity as per SOP.
• Ensure calibration and preventive maintenance of equipment and instruments as per approved schedule and the results of same meeting the standards.
• To initiate and review the request like additional material requisition, material return note, packing material carry forward stereo request and screen request, etc.
• Area and equipment usage documented as per SOP.
• Procurement, receipt nomenclature, issuance, retrieval, and destruction of change parts for packing.
• Online reconciliation and review of batch packing record.
• Preparation and review of Standard Operating Procedures and batch packing record.
• Preparation and review of validation and qualification of process and equipment.
• To organize and implement on-job training of employees and contractual workmen in the department.
• Handling of change controls, deviations, and CAPA through QAMS.
• To perform the investigation related to market complaints, deviations, nonconformities, and implementation of suitable corrective and preventive actions (outcomes of the investigations) within the proposed timelines.
• Coordination between PPC, PM, Engineering, and QC department to have smooth functioning of production activity.
• To ensure proper self-hygiene before entering the production area and follow all the rules and regulations set by the HR department.
• Plan for dispensing activities in accordance with the plan and to coordinate with production planning and control department for timely availability of P.M.
• To ensure 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 and QA head.
• Checking of label, insert/outsert with batch packing record and also retention of all required packing material proof with batch packing record for packing section.
• Troubleshooting: Handling, ensuring, verifying, and troubleshooting of software like bar-coding (1D, 2D), ACG Inspection System for label, blister inspection system, inkjet coding, Data Acquisition System (DAS), and Caliber QAMS.
• Any additional responsibility delegated by the department head.

Work Experience

2 to 5 Years
 

Education

Competencies