Mohamed Anvar Deen — Operations Associate

Senior IT Quality & Compliance professional with 20+ years of total experience, including 18+ years specializing in pharmaceutical IT quality, computerized system validation (CSV), regulatory compliance, and global GxP system implementation. Since 2006, I have led cross-functional teams to execute validation strategies aligned with FDA, EMA, MHRA, and WHO expectations for both on-premise and SaaS-based applications. I currently manage a team of 30+ validation engineers delivering full lifecycle testing and compliance for critical regulated systems. My expertise includes validation and implementation of GxP systems such as SAP, Veeva Vault, TrackWise, LIMS, RLIMS, VMS, and other cloud-hosted platforms across multiple sites and regions. My career includes participation in over 200 regulatory and customer audits, with deep experience ensuring systems are compliant with 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity standards. I am a proven practitioner of Computer Software Assurance (CSA), applying critical thinking to streamline testing and enhance risk-based validation in alignment with FDA’s latest guidance. I bring a strategic mindset to IT compliance and quality assurance—balancing regulatory rigor with business efficiency. I'm actively exploring Senior roles in pharmaceutical, biotech, or IT service organizations where I can lead validation strategy, regulatory readiness, and digital transformation in regulated environments. Core Competencies: • Computerized System Validation (CSV) • Computer Software Assurance (CSA) • GxP Compliance (21 CFR Part 11, Annex 11, GAMP 5) • LIMS / Veeva Vault / TrackWise / SAP / RLIMS / VMS • Audit Readiness (200+ audits supported) • Global Team Leadership (30+ resources) • Risk-Based Validation & Critical Thinking • Quality Systems & Data Integrity • Cloud SaaS GxP Implementation Let’s connect if you’re seeking a results-driven validation leader to elevate your quality and compliance operations globally.

Stackforce AI infers this person is a seasoned expert in Pharmaceutical IT Quality and Compliance.

Location: Chennai, Tamil Nadu, India

Experience: 21 yrs 9 mos