Naresh Devireddy
Computer System Validation Specialist
Hyderabad
Summary
- Over 14+ years of experience in Computer System Validation (CSV) and Computer Software Assurance (CSA) activities within regulated environments.
- Extensive domain expertise in Pharmaceuticals, Healthcare, and Life Sciences, supporting global compliance initiatives.
- Proficient in applying GAMP 5, 21 CFR Part 11, EU Annex 11, FDA guidelines, and GxP/GMP/GDP regulatory frameworks.
- Hands-on validation experience across diverse systems including LIMS, SCADA, QMS, MES, TrackWise, and Veeva Quality Docs.
- Developing, executing, and reviewing validation protocols (IQ, OQ, PQ) for LIMS, SCADA, QMS, MES, TrackWise, and Veeva Quality Docs.
- Skilled in authoring, reviewing, approving, and maintaining comprehensive validation deliverables such as VP, URS, FRS, FRA, DS, IQ, OQ, PQ, TRM, and VSR.
- Experienced in preparing and executing IQ/OQ/PQ protocols using tools like ALM, qTest, and Vera.
- Adept at training and mentoring technical teams, test teams, product owners, and stakeholders on GxP principles, GAMP 5 methodology, and validation best practices.
- Involved in all phases of Software Development Life Cycle (SDLC) and product release processes, ensuring compliance and quality.
- Well-versed in Agile methodologies, supporting iterative validation and continuous improvement.
- Proven ability to collaborate with cross-functional teams across global geographies, ensuring alignment and regulatory readiness.
- Demonstrated leadership in driving quality culture, conducting targeted training sessions to uplift team capabilities.
- Experienced in drafting and updating Standard Operating Procedures (SOPs) in line with evolving regulatory guidance and delivering SOP training across teams.
Overview
15
15
years of professional experience
Work History
GRC Lead
Tech Mahindra
07.2022 - 10.2025
- Define and enforce data governance frameworks aligned with GxP, GMP, and corporate policies
- Collaborate with IT and business stakeholders to align data strategy with compliance objectives
- Conduct risk assessments for data pipelines, analytics platforms, and reporting systems (e.g., FMEA, GAMP5-based)
- Ensure D&A systems comply with 21 CFR Part 11, EU Annex 11, GAMP 5, and internal SOPs
- Oversee validation of analytics platforms (e.g., Azure Synapse, Power BI) and data pipelines (e.g., ADF)
- Train cross-functional teams on GxP data handling, validation lifecycle, and governance principles
- Act as the compliance liaison between business, IT, QA.
Project Quality Manager
UST
11.2018 - 07.2022
- Authored comprehensive Validation Plan and end-to-end validation deliverables in alignment with regulatory expectations
- Led the execution of qualification and validation activities
- Ensured adherence to regulatory timelines, GxP standards, and internal quality benchmarks
- Collaborated cross-functionally with Development, Testing, Product Owners, and Release Management teams to drive validation lifecycle
- Delivered targeted SOP training sessions and facilitated updates to ensure team-wide compliance and awareness
- Reviewed and approved critical validation documentation including URS, FRS, DS, IQ, OQ, and PQ protocols
- Team Size: 10
Validation Lead
BCT
05.2018 - 11.2018
- Reviewed validation documentation in accordance with AstraZeneca’s internal policies and regulatory standards
- Authored, executed, and reviewed validation packages and Standard Operating Procedures (SOPs) to ensure compliance and audit readiness
- Actively contributed to all phases of the validation lifecycle, from planning through execution and closure
- Team Size: 8
Validation Lead
Cognizant
02.2018 - 05.2018
- Developed validation documentation in alignment with GSK’s internal policies and applicable regulatory standards (e.g., GxP, 21 CFR Part 11)
- Served as the primary client interface, managing coordination, status reporting, and change control activities
- Authored and executed validation protocols and Standard Operating Procedures (SOPs) to ensure compliance and audit readiness
- Team Size: 12
SR. Validation Engineer
CSC
08.2010 - 11.2017
- Authored comprehensive Operational Qualification (OQ) protocols, Validation Plans, Traceability Matrices, and Validation Summary Reports in alignment with regulatory expectations
- Executed Installation, Operational, and Performance Qualification (IQ/OQ/PQ) activities and led infrastructure qualification efforts
- Reviewed and revised validation protocols to reflect configuration changes and ensure continued compliance
- Actively contributed to the validation lifecycle and drove continuous improvements in quality processes and documentation standards
Education
Bachelor of Technology - Computer Science and Information Technology
JNTU University
01.2010
Skills
End to End Computer System Validation Activities
Clients
- GSK
- MERCK
- AstraZeneca
- GLENMARK
- NovoNordisk
- BSC
- ThermoFisherScientific
Skills
- End to End Computer System Validation Activities
- Testing
- Selenium
- JAMA
- JIRA
- Service now
- Veeva Quality Docs
- q-Test
- Vera
- Quality ALM
- First Doc
Timeline
GRC Lead
Tech Mahindra
07.2022 - 10.2025
Project Quality Manager
UST
11.2018 - 07.2022
Validation Lead
BCT
05.2018 - 11.2018
Validation Lead
Cognizant
02.2018 - 05.2018
SR. Validation Engineer
CSC
08.2010 - 11.2017
Bachelor of Technology - Computer Science and Information Technology
JNTU University