Senior Officer - Packing (Pen Cartridge) - Sterile/Injectables

Job description

**Job Purpose:** Monitor and execute the packing activities in a shift by maintaining cGMP and safety norms to achieve production targets. **Experience of Pen Cartridge Assemble is must.** **Key Accountabilities:** - Execute shift packing activity by managing available resources and reduces micro stoppage of machine to achieve shift target - Utilise shift resources optimally to get desired production output - Regulate usage of consumables in the production process at optimum level to save cost - Review documentation related to packing activity and monitor standard packing parameters as per BPR to meet regulatory requirement - Review and monitor critical in-process parameters like NFD, camera challenge, RH temperature etc. - Review and perform all operations as per GMP and safety norms by reviewing all processes and documents for compliance - Maintain system integrity by updating online documentation - Perform qualification and calibration of equipment as per schedule and update output of all activities in the system - Prepare manufacturing records and update online documentation to meet production and cGMP requirement - Maintain online documentation and timely entries in BPR and supporting documents by operating SAP and CipDox - Prepare new documents and update existing documents as per GMP requirement. - Monitor adherence to safety guidelines in the block during a shift for packing activities to create safe working environment - Monitor safety systems and ensure procedures are followed in shift and near-miss cases are reported to HSE timely - Ensure availability and usage of PPEs in the shift by coordinating with HSE department - Ensure compliances to safety training targets by monthly reconciling attendance records - Provide training to staff & workmen for packing activity by regular interactions with them to get quality product - Provide training to staff and daily workers for packing activities and safety procedures - Conduct training related to equipment handling, cGMP, documentation and unit operations - Provide new ideas and simplify processes to reduce process cycle time and achieve new targets - Provide new ideas during idea sessions for better productivity with minimum cost - Identify the complexities and suggest process simplification areas to achieve new target with optimum utilization of resources - Reduce and simplify documentation for better accuracy and to meet ALCOA (Attributable Legible Contemporaneous Original Accurate)