Sreenivas Vemula
Computer System Validation (CSV) Compliance Manager at Cognizant
- Role
- Computer System Validation (Csv)- Compliance Manager at Cognizant
- Location
- Rockville, MD, US
- LinkedIn followers
- 500 followers
About Sreenivas Vemula
Highly accomplished Computer System Validation (CSV) Manager with 15 years of specialized…
Experience
Computer System Validation (Csv)- Compliance Manager
Jul 2021 — Present · Hyderabad, IN
Managed GxP compliance, internal and external audits to ensure adherence of all GxP computerized systems to organizational policies, data privacy regulations, and relevant GxP requirements.• Offered comprehensive audit support, facilitating successful compliance audits and ensuring quality standards are upheld during CAPA implementation.• Provided quality oversight for operational activities of GxP systems, including changes, deviations, and periodic reviews, ensuring regulatory compliance.• Performed change impact assessments and managed problems/incidents using the ServiceNow platform.• Conducted periodic reviews of computerized systems to maintain compliance and addressed gaps through the CAPA management tool.• Collaborated with business and IT teams to assess GxP/regulatory applicability and business criticality risks for computerized systems, adhering to client-defined SOPs.• Provided guidance on CSV-related topics and served as the primary point of contact for all CSV-related matters for GxP computerized systems.• Led and managed end-to-end validation activities for GxP-regulated computerized systems, ensuring quality delivery on schedule.• Performed and oversaw Functional Risk Assessments in compliance with GAMP 5, 21 CFR Part 11, FDA regulations, and EU Annex 11.• Defined and executed risk-based testing strategies for CSV projects to ensure compliance and efficiency.• Developed and implemented data migration verification strategies, leveraging ANSI sampling methodologies and industry best practices.• Conducted validation impact analyses and risk assessments for regulatory systems as part of the change management process.• Reviewed and approved validation test deliverables, qualification protocols, GxP changes, and deviations, ensuring timely completion and regulatory alignment.• Supported audits, CAPA implementation, and readiness for regulatory inspections through proactive compliance measures.
Education
Jobs in Warangal
Bachelor of Science (BSc), Mathematics and Computer Science
Kakatiya University, Warangal
Master of Computer Applications - MCA, Computer Science
Jobs in Warangal
Master of Computer Applications (MCA), Computer Science
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