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Kishore K

Associate

About Kishore K


Kishore is an Associate - I at QualiCulture Consulting Group Consultants who has over 13 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 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:       

  • Establish Quality Control Laboratory Systems and  Compose analytical laboratory SOPs in alignment with current regulations
  • Audit Quality Control Laboratories and recommend remediation strategies
  • 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
  • Design and implement systems and procedures to increase the efficiency of multi-plant analytical operations
  • Develop computerized stability systems and computerized tracking programs
  • 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) 
  • 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, GC, UV Spectrophotometer, KF Titrator, Dissolution Apparatus, IR etc.
  • Served as an SME during regulatory inspections (US FDA, MHRA, WHO and TGA etc.)
  • Implement laboratory data management systems

EXPERIENCE:       

  • Deputy Manager  - Quality Control at Laurus Labs Ltd.
  • Group Leader in Analytical Division at Vimta Labs Ltd.
  • Officer in Analytical division at Mylan Laboratories Ltd.

EDUCATION:    

  • Master of Science in Analytical Chemistry


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