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Ragavaiah .M.V

Associate

About Ragavaiah .M.V


Raghavaiah is an Associate - I at QualiCulture Consulting Group Consultants who has over 16 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, stability reports, 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
  • Assist and review CMC sections of FDA submissions for INDs, DMFs, ANDAs and NDAs
  • 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
  • Manage the qualification, preventive maintenance, and calibration of analytical instrumentation
  • Served as an expert in operating analytical instruments such as HPLC, GC, UV Spectrophotometer, KF Titrator, Dissolution Apparatus, IR etc.
  • Served as an SME during regulatory inspections (US FDA, MHRA, WHO and TGA etc.)
  • Auditing of Vendors and Quality Control Laboratories
  • Establish Quality Control Laboratory Systems and  Compose analytical laboratory SOPs
  • Implement laboratory data management systems 

EXPERIENCE:        

  • Senior Manager  - Quality Control at  Megsan Labs.
  • Served as an Analyst, Supervisor to Manager for Analytical Method Development, Validation, Transfer and Quality Control functions at  Divis Labs, Vivimed Labs, Vimta Labs, Laurus labs and Megsan Labs

EDUCATION:        

  • Master of Science in Analytical Chemistry
  • Attended various cGMP training courses


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