About this role
- Preparation, periodic review, revision, and implementation of Standard Operating Procedures (SOPs) of production department.
- Preparation of BMR as and when required.
- Maintain online documentation related to production activities like BMR’s, log books, checklist, balance verification and daily records.
- Monitoring of calibration, verification and support validation activities in production department.
- To Prepare and execute qualification protocol of production department.
- Monitor, control and checking of in process checks during processing related to inspection area.
- Ensuring proper segregation / identification and labelling of batches.
- Batch reconciliation and yield control at various stages of manufacturing.
- Monitoring of environmental conditions during process in manufacturing area.
- Compliance to all regulatory requirements and quality system in the manufacturing department.
- Initiation & investigation of deviation / change control / OOS (Phase-II) of production department.
- Handling of EQMS System for initiation of deviation / change control, CAPA of production department.
- To implementation of training needs identification as per training calendar in production department as a department training coordinator and coordination with concerned department to ensure effective training.
- Supervision of Inspection activity.