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

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)