Viraj Reddy

Skills

Computer System Validation (CSV), 21 CFR Part 11, GxP Compliance, Validation Master Plan (VMP), IQ/OQ/PQ Protocols, Risk Assessment, Data Integrity, ALCOA Principles, ITIL V3, AWS EC2, SOC1/SOC2/SOC3 Reports, Data Center Migration, Infrastructure Qualification, VMWare Qualification, SaaS, PaaS, IaaS, Change Control, Periodic Reviews, Supplier Quality Assessments, Cloud Computing Risk Assessments, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications (DS), Gap Analysis, Requirements Traceability Matrix (RTM), Test Plan Development, Test Case Execution, Defect Tracking, Regulatory Compliance, FDA/EU/MHRA Regulations, SDLC, Disaster Recovery, Failover Verification, Network Performance Monitoring, HP QC, SOP Development, Training, Cross-Functional Collaboration.

About

With over 8 years of experience in the Pharmaceutical and IT industries, I specialize in IT Quality Assurance and Validation, ensuring compliance with FDA, EU, and MHRA regulations. My expertise includes creating Validation Master Plans (VMP), IQ, OQ, and PQ protocols, and leading infrastructure qualification projects such as data center migrations to AWS and cloud-based systems. I have extensive experience in reviewing SOC1, SOC2, and SOC3 reports, qualifying servers, data centers, and network infrastructure, and implementing risk-based approaches to validation. I am proficient in 21 CFR Part 11, ALCOA principles, and ITIL V3 frameworks, with a strong focus on data integrity and audit trail validation. My hands-on experience with SaaS, PaaS, and IaaS platforms, along with my ability to develop and execute test plans, risk assessments, and remediation strategies, has enabled me to deliver compliant and efficient validation solutions across multiple projects.