Naresh Devireddy

Background

About Naresh Devireddy

Experienced Quality Assurance and Computer system validation Professional in Pharmaceutical Domain. Worked on variety of projects enhancement, UAT management, End to End Product validation, Conducting training sessions for business users, Preparation and review of validation deliverables such as URS/FRS, VP, TP, IQ, OQ, PQ/UAT, RTM, VTSR etc. • Experienced professional in Pharmaceutical and healthcare compliance domain with wide experience in GXP, 21 CFR part 11, GAMP 5 and other compliance requirements and adherence. • Specialist in Life Sciences IT Compliance/CSV with extensive experience in FDA (GxP, 21 CFR Part 11), and other regulations. • Experience in providing tactical direction and guidance for project teams implementing Computer Systems for new or existing GxP systems including the development and analysis of system requirements. • Extensive experience in Global IT systems, rollout and management. • Wide exposure in IT implementation in Pharmaceutical, healthcare industry by having executed Deployment, Validation and Maintenance projects to comply with regulatory requirements. • Proficient in reviewing, assisting and creation of Computer System Validation documents like User Requirement Specification, Functional Specifications, Functional Risk Assessments, Requirements Trace-ability Matrix, OQ/PQ Test Protocols, Test Plan, Test Reports and Validation Summary Reports. Acquainted with Agile Methodologies and water fall model. • Tools Used: JIRA, JAMA, HPALM, PIVOTAL. • Certifications: ISTQB, SAFe Agile 4.6.