QA (Assistant Executive – IPQA)

• 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.
  

Requirements