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