Rajesh Chandra Sekaran

About Rajesh Chandra Sekaran

I am a Computer System Validation (CSV) Consultant and Validation Professional with 11+ years of experience supporting healthcare and life sciences organizations in implementing, validating, and maintaining GxP-compliant, inspection-ready computerized systems.My experience spans end-to-end CSV strategy and execution using a risk-based V-Model approach, including validation planning, system classification, risk and impact assessments, IQ/OQ/PQ execution, requirements traceability, and periodic reviews. I also support change control, impact assessment activities, SOP authoring and review, deviation management, CAPA support, and audit readiness, ensuring compliance throughout the complete system lifecycle. My work aligns with global regulatory standards such as GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+) principles.With a solid foundation in testing and quality assurance, I support functional, system, and UAT testing, validation testing oversight, and defect management to ensure validated systems meet both regulatory and business requirements.I collaborate effectively with QA, IT, vendors, and business stakeholders to deliver compliant, reliable, and sustainable validation solutions that balance regulatory expectations with operational efficiency.

Experience

1. Packaged App Development Team Lead

   Accenture in India

   Dec 2025 — Present · Coimbatore, IN

Education

• Park College of Engineering and Technology

  Bachelor of Engineering (B.E.)

  2010 — 2014