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 secure 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
Major Challenges
- Meeting shift targets due to unavailability of adequate resources. Overcome by efficient work load distribution and resource optimisation
- Meeting production targets due to lapses in knowledge transfer between shifts. Overcome by bridging gaps between inter-shift communication
- Maintaining cGMP requirements during system downtime. Overcome by coordinating with the engineering team and technical support team