Geetanjali Abbi

Director Validation, Alkermes

Geetanjali is a Validation, Quality and Compliance engineer with 16 years of strong experience in performing Validation, Quality & Compliance activities for Computerized Systems in GxP/GMP domain, including:

  • Computer System Validation, risk management, inspection readiness, QMS development and harmonization, risk-based testing efforts
  • Detailed functional risk assessments & Root Cause Analysis for CS failures for GxP systems (GAMP-Risk based approach)
  • Developing and reviewing validation deliverables – validation plan, IQ, OQ, PQ, Functional Risk Assessments (FRA), TM, test plan, test case
  • Use of LEAN principle to develop & harmonize QMS
  • Strong communication, problem-solving, and interpersonal skills
  • Ambitious, self-motivated, ability to work independently as well as in teams, possess multi-tasking skills, result-oriented professional
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