Experience

Kalintis Healthcare

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Executive

  • Jul 2021 - Present

   Preparation and Review of Annual Product Review on Yearly basis.  Quality Control Analytical Data reviewer.  Statistical inputs for trending data for OOT, Vendor Evaluation.  Statistical inputs for QMS activity.  Executing release procedure for Finished API, intermediate, Raw Material and Packing Material.  Developing and Reviewing Standard Operating Procedures periodically.  Part of Cross Functional Team in QMS activity.  Preparation and Review of Annual Product Review on Yearly basis.  Quality Control Analytical Data reviewer.  Statistical inputs for trending data for OOT, Vendor Evaluation.  Statistical inputs for QMS activity.  Executing release procedure for Finished API, intermediate, Raw Material and Packing Material.  Developing and Reviewing Standard Operating Procedures periodically.  Part of Cross Functional Team in QMS activity.



SUN PHARMA

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Officer

  • Nov 2018 - Nov 2020

   Preparation and Review of Annual Product Review on monthly basis.  Center of Excellence & Core team member of 21st century quality initiative for product robustness involving activity such as improving sigma level of products attributes, Product understanding report, Product Assessment report, and DMAIC Projects.  Statistical inputs for Continued process verification.  Executing FMEA and DMAIC studies based on data interpretation.  Preparation and Review of Annual Product Review on monthly basis.  Center of Excellence & Core team member of 21st century quality initiative for product robustness involving activity such as improving sigma level of products attributes, Product understanding report, Product Assessment report, and DMAIC Projects.  Statistical inputs for Continued process verification.  Executing FMEA and DMAIC studies based on data interpretation.



New GPC Inc.

• United States

• Quality Assurance Executive

  • Mar 2014 - Apr 2018

  Assisting Quality Control Manager in Reformulating On going formulations and new formulations in accordance with FDA’s requirements. • Calibrating, Handling and performing operations on various analytical instruments like High performance Liquid chromatography(Shimadzu) , Ultra violet Spectroscopy(BUCK M530), Disintegration Apparatus(SOTAX). • Playing a key role in In-house Instrument validation including Design Qualification, Operation Qualification, and Performance Qualification. • Managing and Documenting Retrospective and Concurrent Process validation of the Formulations. • Monitoring and performing analysis on various US-reference standards. Show less