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Prasad S Patil

Associate

About Prasad S Patil


Prasad is an Associate - I at QualiCulture Consulting Group Consultants who has over 10 years of experience in Analytical Method Validation and Quality Control activities. He is responsible for  analytical quality assurance of  analytical testing supporting batch release decisions and regulatory applications. It includes analytical quality assurance activities to ensure product quality and analytical methods reliability for new and commercial products including transfer of analytical method techniques / technology to manufacturing sites.
EXPERTISE:        

  • Establish Quality Control Laboratory Systems and  Compose analytical laboratory SOPs in alignment with current regulations
  • Audit Quality Control Laboratories
  • Prepare, review, audit, and validate analytical records documentation for conformance to commitments and regulations
  • Design and develop analytical methods for the assay, dissolution and stability of pharmaceuticals
  • Perform GMP systems audits of QC and Analytical R & D laboratories
  • Review SOPs, protocols / reports for IQ, OQ, PQ, and other documents for GMP laboratories
  • Perform data integrity assessments in Quality Control laboratories through an in-depth review of analytical data (paper vs electronic data)
  • Compose / review laboratory deviation investigations (OOS, OOT, deviations) and change controls
  • Served as an expert in operating analytical instruments such as  HPLC, UPLC, RRLC, UHPLC, GC, ICP-MS, LC-MS/MS, AAS, Flame Photometer,  UV Spectrophotometer, KF Titrator, Dissolution Apparatus UV and IR etc.
  • Well versed with Empower and Chromeleon software and evaluation of data it compliance with GMP requirements.
  • Served as an SME during regulatory inspections (US FDA, MHRA, WHO and TGA etc.)
  • Implement laboratory data management systems

EXPERIENCE:       

  • Worked as Quality Manager in his last assignment 
  • Worked at Cipla, Mylan Pharmaceutical Inc., Hexagon, Nutralytica Research in various roles related to Quality Assurance and Quality Controls functions.

EDUCATION:        

  • Master of Science in Analytical Chemistry


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