GxP & CSV Compliance : Delivering Validation Excellence
An experienced Computerized System Validation (CSV) specialist focused on regulatory adherence, ensuring GAMP 5 compliance, maintaining full ALCOA++ data integrity and achieving absolute audit-readiness across strictly regulated pharmaceutical and complex IT environments.
Strategic Impact: I specialize in minimizing audit risk exposure and accelerating system deployment cycles, consistently delivering GxP-validated systems while ensuring zero critical findings during major regulatory inspections (USFDA, WHO, MHRA).
Core Expertise & Skills
CSV Strategy • GxP Regulations • Lifecycle Management • Audit Preparedness
Computerized System Validation (CSV)
Managing the entire validation lifecycle from User Requirements Specification (URS) through to Requirement Traceability Matrix (RTM) and Validation Summary Report (VSR), comprehensive IQ/OQ/PQ script preparation and execution and final system release approval, ensuring documented evidence meets regulatory standards.
GAMP 5 & Risk-Based Approach
Expertly applying the GAMP 5 framework to classify systems and implement a strategic, risk-based validation approach (Category 3/4/5 systems), optimizing resources while maintaining maximum compliance integrity.
21 CFR Part 11
Dedicated validation expertise in securing Electronic Records, authenticating Electronic Signatures, and rigorously testing the integrity and functionality of comprehensive Audit Trails to ensure Part 11 compliance.
Regulatory Audits Support
Proven track record of supporting and successfully defending validated systems during audits by major regulatory bodies, including the USFDA, WHO and MHRA, maintaining a history of zero critical findings.
Professional History & Career Milestones
Key roles and achievements in CSV, GxP, and Quality Assurance environments.
CSV Analyst : Samvardhana Motherson Health Solution Limited (SMHS)
Oct 2025 - Present - Noida, UP (Hybrid)
Currently leading validation and deployment of eLogbook systems, ensuring seamless integration with GxP and IT compliance frameworks.
- Establishing audit-ready workflows aligned with 21 CFR Part 11, EU Annex 11, and GAMP 5, focusing on environment-aware deployment.
- Responsible for the full CSV lifecycle, including governance and documentation of the System Development Life Cycle (SDLC).
Executive : Jubilant Pharmova Limited
Mar 2024 - Oct 2025 - Roorkee, UK (On-site)
Led the validation of laboratory informatics systems under GLP/GxP, ensuring full compliance and zero critical observations during regulatory readiness.
- Authored and executed risk-based validation protocols (IQ/OQ/PQ) for critical systems including Tiamo 2.5, Spectrum ES 10.7.2, and ICDAS 3.1.
- Designed and implemented Data Integrity controls and electronic record traceability across cross-functional laboratory teams.
- Successfully defended validated systems during regulatory inspections.
Junior Officer : MACLEODS PHARMACEUTICALS LTD.
Feb 2023 - Jan 2024 - Baddi, HP (On-site)
Contributed to analytical and stability operations, gaining foundational understanding of regulatory documentation required for the U.S. Food and Drug Administration (FDA).
- Gained hands-on experience in Analytical Skills and supporting GxP environments, which informs current CSV testing design.
- Focused on maintaining documentation integrity and stability sample management protocols.
Senior Officer : Alkem Laboratories Ltd.
Jan 2022 - Jan 2023 - Baddi, HP (On-site)
Elevated responsibilities within the Stability division, focusing on advanced analytical methods and quality assurance principles.
- Executed complex analytical tasks in alignment with regulatory filing requirements and GxP standards.
- Actively maintained compliance standards for stability sample management and data reporting.
Apprentice : Alkem Laboratories Ltd.
Jan 2021 - Jan 2022 - Baddi, HP (On-site)
Entry-level experience providing foundational knowledge in pharmaceutical laboratory and GxP standards.
- Trained on stability testing protocols and basic quality control procedures, building core Analytical Skills.
- Established practical understanding of the GxP data flow that precedes computerized system validation.
GxP Systems Validated
Focus on Data Integrity (ALCOA++) and System Security
eLogbook System (GMP Logbooks Digitization)
Led the validation and full deployment of digital GMP logbooks, ensuring the system met operational efficiency and regulatory requirements across the facilities.
- Successful implementation and verification of robust audit trail mapping for all GxP events.
- Designed, tested, and verified comprehensive role-based access management (RBAC) based on defined user roles and privileges.
- Validated the integrity of electronic signatures (21 CFR Part 11) within the system.
- Verified secure long-term archival and compliant data retrieval capabilities.
Tiamo 2.5 Systems
Provided full validation scope for this critical analytical control software (used for Auto-Titrators, pH meters and Conductivity meters), ensuring high data accuracy, process integrity, and system resilience for quality control operations.
- Detailed Instrument Qualification (IQ) and operational qualification (OQ) protocol execution.
- Rigorous validation of all calculation methods, calibration functions, and protocol development in line with USP/EP requirements.
- Verified role based access, tested Disaster Recovery and secure archival procedures.
Spectrum ES 10.7.2 (FTIR)
A critical Data Integrity validation project focusing on the complex control software for Fourier-transform infrared spectroscopy (FTIR), ensuring compliance with strict GxP and 21 CFR Part 11 principles.
- Executed, documented audit trail review and challenged security functions to ensure data integrity (ALCOA++).
- Developed and verified user privilege assignment matrices (UPAM) to restrict data manipulation.
- Validated system architecture and performed installation qualification (IQ) on all related client workstations.
- Ensured compliant change control and periodic review documentation for continued validation maintenance.
GxP Excel Spreadsheet Validation
Managed the validation and lifecycle documentation for critical GxP spreadsheets used for calculations, data analysis, and master data management in QC labs.
- Performed category-based risk assessment (GAMP 5) for COTS and custom spreadsheets (e.g., potency calculations).
- Authored and executed validation protocols covering formula verification, security, access control, and data integrity checks.
- Implemented version control and established procedures for periodic review and change management for all GxP templates.