Officer - Packing/Production - Sterile/Injectables

Job Purpose

Monitor and execute the production activities in an area during the shift by maintaining cGMP and safety norms to achieve production targets

Key Accountabilities

Execute production activities in a shift by managing available resources to achieve production target

• Execute assigned tasks as per planned production activity to meet production targets for a shift
• Regulate usage of consumables in the production process at optimum levels to save costs
• Increase the efficiency of area by utilization of equipment and by reducing downtime in manufacturing area

Maintain standard process parameters as per BMRs and other supporting documents for achieving production target and maintaining quality

• Ensure all operations are performed as per GMP & Safety norms by reviewing all processes and documents for compliance
• Ensure equipment, facility and block premises are maintained as per regulatory compliance
• Maintain system integrity by updating documentations and deviations on CipDox while performing operations
• Perform validation, qualification and calibration as per schedule and update output of all activities in the systems
• Prepare new documents and update existing documents as per GMP requirement

Prepare manufacturing records and update online documentation to meet production and cGMP requirements

• Maintain online documentation and timely entries in BMR and supporting documents
• Prepare new documents and update existing documents as per GMP requirement
• Operate software such as SAP, CipDox and QMS

Follow safe work processes and ensure safety appliances are utilised during production activities in shifts to create a safe working environment

• Ensure safety systems and procedures followed by the operators in the shift
• Ensure availability and usage of PPEs in the shift by coordinating with HSE department for requirements and shift schedule

Execute production activities in a shift by managing available resources to achieve production target

• Execute assigned tasks as per planned production activity to meet production targets for a shift
• Regulate usage of consumables in the production process at optimum levels to save costs
• Increase the efficiency of area by utilization of equipment and by reducing downtime in manufacturing area