Junior Officer

DivisionDepartmentSub Department 1Job PurposeMonitor and execute the packing activities in a shift by maintaining cGMP and safety norms to achieve production targetsKey Accountabilities 1 6 Execute shift packing activity by managing available resources and reduces micro stoppage of machine to achieve shift targetxc2xb7 Utilise shift resources optimally to get desired production outputRegulate usage of consumables in the production process at optimum level to save costKey Accountabilities 2 6 Review documentation related to packing activity and monitor standard packing parameters as per BPR to meet regulatory requirementxc2xb7 Review and monitor critical in-process parameters like NFD camera challenge RH temperature etc xc2xb7 Review and perform all operations as per GMP and safety norms by reviewing all processes and documents for compliancexc2xb7 Maintain system integrity by updating online documentationPerform qualification and calibration of equipment as per schedule and update output of all activities in the systemKey Accountabilities 3 6 Prepare manufacturing records and update online documentation to meet production and cGMP requirementxc2xb7 Maintain online documentation and timely entries in BPR and supporting documents by operating SAP and CipDoxPrepare new documents and update existing documents as per GMP requirementKey Accountabilities 4 6 Monitor adherence to safety guidelines in the block during a shift for packing activities to create safe working environmentxc2xb7 Monitor safety systems and ensure procedures are followed in shift and near-miss cases are reported to HSE timelyxc2xb7 Ensure availability and usage of PPEs in the shift by coordinating with HSE departmentEnsure compliances to safety training targets by monthly reconciling attendance recordsKey Accountabilities 5 6 Provide training to staff workmen for packing activity by regular interactions with them to get quality productxc2xb7 Provide training to staff and daily workers for packing activities and safety proceduresConduct training related to equipment handling cGMP documentation and unit operationsKey Accountabilities 6 6 Provide new ideas and simplify processes to reduce process cycle time and achieve new targetsxc2xb7 Provide new ideas during idea sessions for better productivity with minimum costxc2xb7 Identify the complexities and suggest process simplification areas to achieve new target with optimum utilization of resourcesReduce and simplify documentation for better accuracy and to meet ALCOA Attributable Legible Contemporaneous Original Accurate Major Challengesxc2xb7 Meeting shift target due to unavailability of adequate resources Overcome by efficient work load distributionMaintaining cGMP requirements during system downtime Overcome by coordinating with engineering and technical support teamKey Interactions 1 2 xc2xb7 Quality assurance and control for batches release as per packing plan Daily xc2xb7 Engineering for preventive maintenance and help in modification as per need xc2xb7 Safety for awareness training and near miss issue Daily Store for daily dispensing plan and availability of packing materials Daily basis Key Interactions 2 2 Maintenance contractor for any machine repairs Need Based Dimensions 1 2 xc2xb7 Direct Reports 3xc2xb7 Achieve average volume of 200 mn FY2015-16 xc2xb7 Average number of BPRs handled 200xc2xb7 Average number of batches in packing 200xc2xb7 Average number of sales order dispatched 80xc2xb7 Achieve internal OTIF more than 90 xc2xb7 Achieve Zero reportable accidents incidences during packing activitiesxc2xb7 Achieve 0 errors in online documentationMeet 100 compliance to SOP and Safety regulationDimensions 2 2 Key Decisions 1 2 Resources allocation and work distribution for each shiftKey Decisions 2 2 xc2xb7 Up-gradation in facility and documents to Section Head - Packingxc2xb7 Modification in equipment to Section Head - PackingDeviation and implementation of CAPAs Section Head - PackingEducation QualificationB Pharm B Sc Chemistry Relevant Work Experience1-5 years of experience in packing with knowledge of handling of QMS activity qualification and other related documents