Compliance . Resilience . Delivered .
A Cyber & Digital Risk professional at PwC India with deep hands-on experience in Computerized System Validation (CSV) and GxP compliance across highly regulated Pharmaceutical and MedTech organizations. I bring a practical, risk-based perspective to advisory engagements — built on real validated-environment exposure and regulatory expectations.
Strategic Value: I work at the intersection of technology, regulation, and business risk — helping organizations navigate IT GRC, ISO frameworks, and digital governance while ensuring systems are not only compliant, but also resilient and audit-ready. My validation background directly informs how I approach cyber risk, data integrity, and system controls for enterprise clients.
Core Expertise & Skills
Cyber Risk • IT GRC • System Validation • Data Integrity • Digital Advisory
Cyber & Digital Risk Advisory
Advising regulated organizations on Cyber & Digital Risk at PwC India, translating complex technical and compliance risks into actionable business insights. Focused on aligning technical controls with enterprise-level digital trust and supporting clients in navigating evolving regulatory and threat landscapes.
IT GRC & ISO Frameworks
Applying IT Governance, Risk, and Compliance (GRC) principles alongside ISO frameworks to assess and strengthen organizational risk posture. Conducting Technical Risk Assessments and supporting the design of control environments that meet both regulatory and business resilience requirements.
Computerized System Validation (CSV)
Extensive hands-on experience managing the full validation lifecycle — from URS and risk assessment through IQ/OQ/PQ execution to VSR and system release — under GAMP 5, V-Model, and SDLC frameworks. This foundation directly informs a rigorous, evidence-based approach to cyber advisory engagements.
Data Integrity & ALCOA++ Principles
Deep expertise in ALCOA++ data integrity principles, secure data migration, and system controls for GxP environments. Experienced in designing and verifying audit trails, electronic records, electronic signatures, and role-based access controls compliant with 21 CFR Part 11 and EU Annex 11.
Professional History & Career Milestones
From GxP Validation & Quality Assurance to Cyber & Digital Risk Advisory at PwC India.
Associate - Cyber & Digital Risk Advisory : PwC India
Mar 2026 - Present - Gurugram, Haryana (Remote)
Leveraging a strong foundation in CSV and GxP compliance to deliver practical, risk-based advisory to clients in regulated Pharmaceutical and MedTech sectors, working at the intersection of technology, regulation, and business risk.
- Applying GAMP 5, V-Model, and SDLC expertise to cyber and digital risk engagements, ensuring systems are compliant, resilient, and audit-ready.
- Supporting IT GRC, ISO frameworks, and Technical Risk Assessments to align technical controls with enterprise-level digital trust objectives.
- Translating ALCOA+ data integrity principles and secure data migration experience into actionable cyber and digital risk insights for clients.
Executive : Jubilant Pharmova Limited
Mar 2024 - Nov 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
Eurotherm Bridge 5.7
Led the validation, configuration, and deployment of Eurotherm Bridge v5.7 ensuring compliance with GxP and 21 CFR Part 11 requirements and reliable operational use across regulated manufacturing facilities.
- Supported validation of system audit trail functionality, confirming accurate capture, storage, and retrieval of all relevantuser activities and GxP‑impacting events within Eurotherm Bridge 5.7.
- Tested, and verified role‑based access control (RBAC) ensuring user authentication, authorization, and privilege enforcement aligned with defined operational roles and data integrity requirements.
- Verified secure long‑term data archiving and compliant data retrieval through Eurotherm Bridge 5.7, ensuring data integrity, traceability, and availability throughout the record retention lifecycle.
eLogbook System
Led the validation and full deployment of eLogbooks, 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 Spreadsheets
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.
Get in Touch...
kshatriya205902@gmail.com
Time Zone
IST[GMT+05:30]
Location
Gurugram, India