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Md. Sakil Amin joined square pharmaceutical limited in December 2008 as Executive, Quality Assurance. I was responsible for In-process check in solid dosage form, small volume parenteral, large volume parenteral, Meter Dose inhaler and insulin manufacturing area. Also responsible for release for bulk product and finished product and prepare APQR in all areas for next two years.

In 2011 i was assigned for handling critical documentation of Quality assurance department like QIR and deviation. I was also assigned for monitoring the manufacturing process of ANDA submission batch and handled all the critical document associated with ANDA submission. Review all the document of ANDA submission batch and prepare for submission.

In 2013 i was promoted to the nest position and assigned for monitoring tool manufacturing activities in RAK pharmaceutical limited and put responsibilities for all the activities in RAK pharmaceuticals limited.

In 2013, i was also assigned for maintaining proper documentation of all the critical documentation in Quality Assurance department and face he international audit. I have handled critical documentation like deviation, customer complaint, rejection, out of specification, out of trend, QRM, CAPA and APQR. I have faced USFDA, TGA, MHRA, WHO and many audit from different regulatory body successfully.

In January 2015, I have promoted as Sr. Executive Quality Assurance and assigned as supervisor Investigation and CAPA management. I am responsible to lead my team to investigate the quality incident & out of specification in solid and sterile area, finding the root cause of the incident and proposed CAPA to stop reoccurrence. My team is responsible to handle the customer complaint, rejection, recall and perform the risk assessmnet associated with the incident. I have worked as an active member for the USFDA pre approval audit and after successful completion i am currently working for the USFDA post approval audit.


  • Pharmacovigilance
  • Deviation management
  • Risk Management
  • CAPA Management
  • Change Control Management
  • Qualification, Validation and Calibration
  • Cleaning Validation
  • Regulatory Submission
  • Batch Release
  • APQR
  • In-process Monitoring
  • Treand analysis

Job History

Techno Drugs Ltd

Square Pharmaceuticals Ltd

Sunman-BIRDEM Pharmaceuticals Ltd

ACME Laborotories Ltd

Education History

Masters in Pharmacy

Bachelor in Pharmacy