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Vinod S Wagh

Associate

About Vinod S Wagh


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

  • Experience and knowledge of analytical method development, validation protocols / reports and laboratory investigation / OOS
  • Manage and coordinate analytical method transfer projects with cross-functional project teams (R&D, QC, QA) 
  • Coordinate activities related to analytical method transfers; review analytical methods; plan / oversee method feasibility studies; review method transfer protocols and reports
  • 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
  • Compose / review laboratory deviation investigations (OOS, OOT, deviations) and change controls
  • Manage the qualification, preventive maintenance, and calibration of analytical instrumentation
  • Served as an expert in operating analytical instruments such as  UPLC-PDA-FLD-PCD, HPLC-IRD, HPLC-VWD, FTIR, ELISA,DISSOLUTION,ICP-MS,LC-MS/MS etc.
  • Served as an SME during regulatory inspections (US FDA, MHRA, WHO and TGA etc.)
  • Establish Quality Control Laboratory Systems and  Compose analytical laboratory SOPs
  • Implement laboratory data management systems 

EXPERIENCE:      

  • Served as an Analyst and Supervisor for Analytical Method Development, Validation and Quality Control functions at  Nutralytica Research Pvt Ltd. 

EDUCATION:     

  • Graduation in Chemistry
  • Attended various cGMP training courses


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