About the role
- Preparation, Review and Issuing control of BMR and BPR
- Handling of Change control, Deviation, CAPA, and Investigation on the shop floor.
- Preparation and Review of SOP and All formats of manufacturing and packing.
- Preparation and control of Validation protocol and involvement in process validation.
- In process monitoring during Dispensing, Granulation, Compression, Coating and Hard gelatin capsule filling.
- In process monitoring during packing operation.
- Dispensing area
- Manufacturing area (Granulation, Compression, Coating, Inspection and Capsule filling area)
- Packing Area (Primary and secondary packing area)
- Swab and Rinse sampling.
- Inspection of packing goods for evaluation of physical attribution before and after completion of final packing.
- Finished product sampling and Batch record review.
- Sampling activity during process and validation.
- Calibration of instruments (D.T, Friability, Hardness Tester and Weighing balance) as per schedule.
- To carry out validation batches sampling as per process validation protocol.
- To ensure in-process controls are performed during manufacturing operations and results are satisfactory.
- Overall responsibility to review BMR, Logbooks, In-process formats and other online records.
- To perform cleaning validation sampling as per cleaning validation protocol.
RequirementsEligibility – B. Pharma/M. Pharma