Job
Description
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 Graduation in Pharmacy Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility
