Role & Responsibilities
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.
Step wise line clearance in:
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.
Requirements
Eligibility – B. Pharma/M. Pharma
📌 Qa Assistant Executive Ipqa Basdehra
🏢 Leading
📍 Basdehra
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