Nawaz Ali
Chennai
Summary
Results-driven Validation Manager with 13+ years of experience across Computer System Validation (CSV) and Software Testing in regulated industries (Pharma & Healthcare). Expert in GxP Compliance, 21 CFR Part 11, Annex 11, and Data Integrity. Proven leader in driving validation lifecycle excellence, audit readiness, and cross-functional collaboration to deliver compliant, high-impact systems.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Validation Manager
Capgemini Technology Services India Limited
09.2023 - Current
- Provided end-to-end Quality and Compliance Oversight for Computerized Systems, ensuring adherence to GxP, 21 CFR Part 11, EU Annex 11, and Data Integrity requirements across the system lifecycle.
- Oversaw and approved 21 CFR Part 11, Annex 11, and Data Integrity assessments, ensuring systems meet regulatory requirements for electronic records and electronic signatures.
- Reviewed and approved validation deliverables (URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Summary Reports) to ensure compliance with CSV best practices and global regulatory expectations.
- Led and facilitated GxP risk assessments for computerized systems, ensuring appropriate risk-based validation strategies and regulatory alignment.
- Managed and approved Change Control activities for GxP systems, maintaining validated state and ensuring thorough assessment, documentation, and implementation of changes.
- Directed Periodic Review of GxP Systems, including evaluation of system performance, compliance status, deviations, and CAPA effectiveness.
- Ensured timely CAPA management, including tracking, follow-up, effectiveness checks, and closure in compliance with quality standards.
- Communicated audit and assessment outcomes to stakeholders and senior management, delivering risk-based recommendations and actionable remediation strategies.
- Clients: Kenvue Inc - Life Sciences and Pharmaceutical, Abbvie Inc - Life Sciences and Pharmaceutical
Senior Technical Lead (CSV Consultant)
HCL Technologies Ltd.
06.2020 - 11.2022
- Developed and maintained comprehensive GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications (URS), Design Specifications, IQ/OQ/PQ protocols, Risk Assessments, Requirement Traceability Matrices (RTM), and Validation Summary Reports.
- Supported the implementation of Quality Systems in compliance with FDA 21 CFR Part 11 (electronic records, electronic signatures, and audit trails), 21 CFR Part 820, and GAMP 5 guidelines.
- Developed and executed OQ and PQ protocols, ensuring full coverage of system requirements through maintained Requirement Traceability Matrices.
- Authored and executed validation strategies, managed documentation reviews, and addressed deviations to meet regulatory expectations.
- Ensured data integrity and compliance across integrated systems and interfaces, supporting audit readiness and system reliability.
- Reviewed and adhered to Standard Operating Procedures (SOPs) to align processes with FDA regulatory standards.
- Collaborated with cross-functional teams and stakeholders to establish a robust, end-to-end validation approach for GxP applications.
- Client: Jabil Inc.
- The objective of this project is to establish and implement new Quality Management System for the recently bought Medical Devices manufacturing facilities
Senior Consultant (CSV Consultant)
PHILIPS Healthcare (On a payroll of Cibersites)
08.2019 - 06.2020
- Prepared Computer System Validation (CSV) deliverables in alignment with GAMP 5, FDA 21 CFR Part 11, and internal quality standards.
- Defined and delivered key documentation for Non-Product Software System (NPSS) validation, including URS, FRS, Validation Plans, 21 CFR Part 11 assessments, and IQ/OQ/PQ test scripts.
- Ensured data integrity and compliance across integrated systems, utilising platforms such as ValGenesis and Docker.
- Facilitated requirement-gathering discussions, assessed system scalability, and performed risk assessments to enhance validation planning.
- Collaborated with business stakeholders, technical teams, Validation Managers, and Business Analysts to finalize user stories for Agile development.
- Maintained and updated Requirement Traceability Matrices (RTM) to ensure full traceability between requirements and test cases.
- Compiled validation outcomes and release details into Validation Summary Reports (VSRs) to document and communicate validation activities effectively.
- Actively participated in daily Scrum meetings, contributing to discussions on validation processes, blockers, and continuous improvement opportunities.
Senior process Consultant (CSV Consultant)
Galax E Solutions India Pvt Ltd.
10.2018 - 08.2019
- Conducted compliance assessments ensuring strict adherence to regulatory standards.
- Facilitated assessment and implementation of FDA 21 CFR Part 11 compliance.
- Conducted FMEA-based risk assessments to define validation strategy.
- Prepared Validation Plans (VP) and Validation Summary Reports (VSR).
- Reviewed and supported execution of IQ, OQ, and PQ protocols, facilitating successful validation outcomes.
- Managed deviations and periodic reviews, implementing CAPA activities to enhance compliance and operational integrity.
- Client: Johnson & Johnson
Validation Manager
Move Offshore Pvt Ltd.
06.2013 - 06.2017
- Led requirement discovery by collaborating with founders and cross-functional teams to translate business ideas into scalable product features.
- Collaborated with developers and QA in a fast-paced environment to build, iterate, and launch solutions efficiently.
- Coordinated UAT and defect tracking, ensuring swift resolutions and high-quality product releases in an agile setup.
Technical Analyst (CSV)
Cognizant Technology Solutions India Pvt Ltd
03.2011 - 04.2013
- Developed and executed validation and qualification documents (URS, FS, DS, IQ, OQ, PQ, and reports) to ensure compliance with 21 CFR Part 11, GxP, and GAMP guidelines.
- Prepared and reviewed validation strategies, documentation, and deviation management activities, facilitating effective compliance oversight.
- Drafted, reviewed, and approved test scripts, ensuring thorough system validation and adherence to regulatory standards.
- Executed UAT and OQ processes, providing support during the absence of business users.
Test Analyst
Cognizant Technology Solutions India Pvt Ltd
09.2005 - 02.2011
- Executed end-to-end manual testing activities, creating and designing test scenarios and cases to ensure alignment with functional requirements and application quality.
- Conducted diverse testing types such as functional, regression, integration, UI, and system testing to ensure application quality.
- Reviewed test cases, validated objective evidence, and tracked defects using standard bug tracking tools to maintain testing integrity and facilitate issue resolution.
- Developed and maintained testing artifacts, including Test Summary Reports and Requirement Traceability Matrix (RTM), to ensure comprehensive test coverage and traceability throughout the testing process.
Education
Bachelor of Electronic Science -
Skills
- Strong expertise in Coputer System Validation (CSV) with end-to-end validation deliverables
- Proficient in IQ, OQ, and PQ validation execution
- Experienced in Agile and Waterfall project environments
- Solid background in software testing, defect management, and documentation
- Good knowledge of SDLC/STLC processes
- Proven team handling and coordination skills
- ITIL V3 & ISTQB certified professional
Tools Skills
JIRA, Xray, HP-ALM, ValGenesis, SOLMAN, Agile Doc-ER, DocuSign, DocSpace, ServiceNOW
Languages
English
Advanced
C1
Tamil
Advanced
C1
Certification
- ISTQB
- ITIL V3
Timeline
Validation Manager
Capgemini Technology Services India Limited
09.2023 - Current
Senior Technical Lead (CSV Consultant)
HCL Technologies Ltd.
06.2020 - 11.2022
Senior Consultant (CSV Consultant)
PHILIPS Healthcare (On a payroll of Cibersites)
08.2019 - 06.2020
Senior process Consultant (CSV Consultant)
Galax E Solutions India Pvt Ltd.
10.2018 - 08.2019
Validation Manager
Move Offshore Pvt Ltd.
06.2013 - 06.2017
Technical Analyst (CSV)
Cognizant Technology Solutions India Pvt Ltd
03.2011 - 04.2013
Test Analyst
Cognizant Technology Solutions India Pvt Ltd
09.2005 - 02.2011