Kuber Singh (He/Him)

I am a Data Integrity specialist and Computer System Validation professional with over 20 years in pharmaceutical manufacturing — currently serving as the IT – QA Executive at National Pharmaceutical Industries Oman. I have direct, hands-on experience with ALCOA+ principles, audit trail reviews, ER/ES compliance under 21 CFR Part 11, and GxP data integrity across complex pharmaceutical environments — applied under USFDA, EU GMP, and MHRA regulatory scrutiny.

My approach is pragmatic: I build solutions that are compliant without being unnecessarily disruptive to operations, and I guide teams through DI requirements in a way they can actually implement and sustain.

IT QA Executive — Site Data Integrity Lead & CSV Program Owner at National Pharmaceutical Industries Co (SAOC) (2021-09 – Present)

General & Beta-Lactam Pharmaceutical Manufacturing. Own the site Data Integrity programme end-to-end — holding the DI policy, maintaining the site-wide data integrity risk assessment, and coordinating with Business System Owners and Technical System Owners across manufacturing and analytical functions to identify gaps and drive remediation to closure.

• Lead data integrity gap assessments across GxP computerised systems — mapping data flows through manufacturing and analytical equipment (analytical instruments, manufacturing systems, execution systems), assessing risks at each step of the data flow, and producing data risk assessment reports that are reviewed and approved by Quality and the business.
• Design both short-term control strategies (interim procedural controls, access restrictions, audit trail configuration) and long-term remediation plans for non-compliant systems — finding solutions the business can actually implement without stopping operations.
• Identify the most efficient action for any system at any step of the data flow — working with Business System Owners, Technical System Owners, QA, and Training to balance regulatory requirements with operational practicality.
• Improve the procedural framework for Data Integrity — writing and revising SOPs, WISOPs, and policies covering audit trail review requirements, access control standards, backup and recovery verification, and data integrity training obligations across the site.
• Guide Business System Owners and Technical System Owners in meeting current FDA, EMA, and MHRA Data Integrity expectations and preparing for evolving regulatory guidance — translating complex regulatory language into practical actions they can own.
• Manage audit trail reviews for all GxP laboratory and manufacturing computerised systems — Chromeleon 6.8 (HPLC/GC), UV-Vis, FTIR, AAS, Particle Size Analyser, Viscometer, and Temperature Monitoring Systems — ensuring electronic records are complete, accurate, and attributable under ALCOA+ principles.
• Serve as DI and CSV Subject Matter Expert during USFDA, EU GMP, and MHRA regulatory inspections — zero critical Data Integrity observations across all external inspections supported.
• Lead CAPA management for DI events — conducting root cause analysis, proposing technical and procedural remediations, coordinating with stakeholders, and tracking all actions to verified closure.
• Validate and qualify manufacturing equipment (FBD, Tablet Compression — Bosch/Sejong, Coating — Bosch, Liquid Filling — Bausch & Strobel/Jekson) and analytical laboratory instruments — full IQ/OQ/PQ lifecycle including FAT and SAT, applying GAMP 5 risk-based methodology throughout.
• Oversee enterprise data backup (Acronis) and disaster recovery programmes for critical GxP systems — ensuring documented, tested recovery capabilities are in place and inspection-ready.

IT QA Officer — Data Integrity & Computer System Validation at National Pharmaceutical Industries Co (SAOC) (2018-07 – 2021-09)

• Delivered hands-on DI compliance work across GxP computerised systems — audit trail configuration and review, user access controls, ER/ES compliance verification — building the data integrity foundations later scaled to site-level programme ownership.
• Authored and executed IQ/OQ/PQ validation protocols for manufacturing and laboratory systems, managed change controls, and maintained validated-state compliance under 21 CFR Part 11 and EU Annex 11.
• Managed CAPA programs for data integrity and IT system events — root cause analysis, action coordination, and verified closure.
• Participated in internal and external regulatory audits as the IT Quality and Data Integrity representative — preparing inspection documentation and supporting audit-ready evidence packages.

Senior Executive — CSV & IT Quality Compliance at Wipro Ltd. (Deployed: Novartis Healthcare Pvt. Ltd.) (2010-09 – 2018-06)

Global Pharmaceutical Manufacturing. Worked within a complex, multinational pharmaceutical manufacturing environment — applying GAMP 5, 21 CFR Part 11, and EU Annex 11 across GxP computerised systems in a globally regulated Novartis facility. Gained deep practical experience in data integrity controls — audit trail management, user access governance, electronic record integrity, and ER/ES compliance under 21 CFR Part 11 — across chromatography systems (Chromeleon 6.8), HPLC, GC, and laboratory analytical platforms.

• Led end-to-end development and execution of CSV lifecycle documentation: URS, Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, FAT/SAT reports, Traceability Matrices, and Compliance Reports.
• Served as Subject Matter Expert for computerised systems during regulatory inspections and customer audits — providing independent compliance expertise and generating responses to audit observations.
• Managed Change Control processes through the QMS — reviewing change requests, assessing data integrity risk at each step, and maintaining validated-state integrity across all GxP systems.
• Designed and implemented Disaster Recovery and Business Continuity frameworks for critical GxP IT systems — end-to-end project ownership from risk assessment to tested implementation.

Windows Administrator — Team Lead at Wipro Ltd. (2007-06 – 2010-09)

Managed Windows Server environments, Active Directory, DNS/DHCP, file servers, and enterprise backup/recovery across multi-site infrastructure — the IT foundation later applied directly to GxP computerised system governance and data integrity controls.

Windows Administrator at Hydrocare Fluid Power Systems (2005-05 – 2007-06)

Network and systems administration for a 35+ system LAN environment. End-user hardware and software support.

Diploma in Electronics & Communications Engineering – Sri Venkateswara University (Loyola Polytechnic, Pulivendula) (2001 – 2004)