Soma Sekhara Venkat Reddy Annapureddy

Computer System Validation (CSV) aspirant with over 11 years of experience in the pharmaceutical industry, specializing in Analytical Method Development and Validation within GMP-regulated environments. Recently trained in CSV with practical knowledge of 21 CFR Part 11, EU GMP Annex 11, CSA, risk-based testing, and the SDLC-based validation lifecycle. Demonstrated expertise in working with validated systems such as Empower3 and TrackWise. Experienced in authoring protocols and reports, participating in regulatory inspections, and ensuring compliance with quality standards. Adept at applying testing methodologies, managing documentation, and maintaining regulatory compliance—poised to transition successfully into a GxP software validation or CSV role.

GPAT qualified in 2011 with a percentile of 95.0

NIPER qualified in 2011

Clinical SAS Base Programming certification

Machine Learning Advanced by Accredian

• Computer system validation life cycle management and validation documentation: URS, FS, IQ, OQ, PQ, UAT, traceability matrix, validation plan, and validation summary report
• Good knowledge of the software development life cycle (SDLC) process, which is used for planning, creating, testing, and deploying computerized systems
• Well-versed in linear and agile methodologies
• Regulatory compliance: 21 CFR Part 11, GAMP5, Annex 11, FDA CSA
• Authored, reviewed, and approved all validation documents, including the validation plan and reports
• Validation strategy development
• Updating validation approaches from CSV to CSA
• Development of validation approaches, test strategies, test cases, test plans, test procedures, test requirements, and testing standards
• Quality systems and tools: D2 Documentum, Empower3, TrackWise, HP ALM, JIRA
• Risk and quality management: QMS implementation, risk assessments, CAPA, change management, deviation management
• Cross-functional collaboration: QA, QC, IT, engineering, and system owners