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Description: Division Department Sub Department 1 Job Purpose Operate & maintain packing machines to achieve quality product & shift wise targeted output with maximum utilisation. Key Accountabilities (1/6) Prepare the machine for packing operation as per production plan by using proper resources to ensure smooth operations - Perform calibration, clean and set different equipment and machines as per SOP and schedules for on-time completion of batch processing - Check the suitable change part as per product requirement - Arrange change parts & stereo for batch packing activity Key Accountabilities (2/6) Operate the packing machines by using minimum resources to get quality product - Evaluate the product dimensions and set the machine for changeovers - Perform in-process checks in packing machines to ensure proper functioning of machine - Perform labelling and handle rejection control in packing machine - Reduce micro stoppages and avoid non-conformances during packing machine operations, cleaning and line clearance - Maintain equipment, facility and block premises as per SOP for audit readiness and to avoid critical and major observation - Perform all operations as per cGMP and safety to reduce rejection Key Accountabilities (3/6) Execute and update online documentation to meet cGMP requirements and maintain data integrity Fill Machine logs. Document entries/SOP and process simplification to meet cGMP. - Fill Machine logs & other relevant documents precisely to meet cGMP requirements - Check documentation before submission to ensure data integrity - Conduct training related to cGMP, equipment operation, for workmen to minimize deviation from procedure - Provide technical support to operators about packing activity and cGMP to get quality output for any up-gradation during packing activity Key Accountabilities (4/6) Perform packing machine operations safely to avoid safety incidences by appropriately handling the machines and thereby maintaining high standard of safety - Perform regular interlock checks of packing machines and perform safe operations - Ensure usage and maintenance of PPEs by workmen during shifts - Report any near-miss to officer in-charge in time Key Accountabilities (5/6) Deliver training to workmen and adhere cGMP and safety guidelines in production process to ensure smooth operations - Provide training to other operators about secondary packing machine settings and operations - Conduct training related to safety and housekeeping for workmen - Participate in learning of new machine and build expertise in troubleshooting the machines Key Accountabilities (6/6) Major Challenges - Meeting shift target due to unavailability of adequate resources. Overcome by efficient work load distribution - Maintaining cGMP requirements during system downtime. Overcome by coordinating with engineering and technical support team - Low yield due to more rejections. Overcome by controlling rejection and simplification of process and attending training Key Interactions (1/2) - Store for daily dispensing plan and availability of packing materials (Daily basis) - Engineering for preventive maintenance and help in modification (as per need) Key Interactions (2/2) Maintenance contractor for any machine repairs (Need Based) Dimensions (1/2) - Achieve average volume of 60 mn (FY2015-16) - Average number of BPR’s handled : 60 - Average number of batches in packing : 60 - Average number of sales order dispatched : 25 - Achieve internal OTIF more than 90% - Achieve Zero reportable accidents/ incidences during packing activities - Achieve 0% errors in online documentation - Meet 100% compliance to SOP and Safety regulation Dimensions (2/2) Key Decisions (1/2) - Up-gradation in facility and documents to Section Head - Packing - Modification in equipment to Section Head - Packing - Deviation and implementation of CAPAs Section Head - Packing Key Decisions (2/2) Education Qualification Diploma (Engineering / Pharmacy) Relevant Work Experience 0-2 years of experience in packing with knowledge of handling of QMS activity, qualification and other related documents