Sandesh Zade

About Sandesh Zade

Computer System Validation (CSV) Consultant & Validation Engineer with 3+ years of…

Experience

1. Validation Engineer

   Accenture

   Jul 2022 — Present · Bhopal, IN

   Executed Computer System Validation (CSV) deliverables across 5+ pharmaceutical manufacturing sites, ensuring compliance with GxP, 21 CFR Part 11, and EU Annex 11.Delivered complete validation lifecycle documentation (URS, VP, FS, FRA, DS, IQ, OQ, PQ, Traceability Matrix, VSR) with audit-ready quality.Performed SCADA (iFIX) validation, server qualification, PLC/HMI validation, and standalone system validation for production and packaging lines.Led system decommissioning and archival activities, including access control and data migration, aligned with regulatory standards.Collaborated with QA, IT, and Production teams to close validation gaps, manage deviations, and maintain compliance.Achieved zero data integrity issues across multiple client audits and regulatory inspections.Key Client Projects & Achievements:Mylan (Ahmedabad, Aurangabad & Indore): Completed end-to-end validation of QC, Manufacturing, and Packaging systems with zero compliance findings; executed system decommissioning activities.USV (Baddi): Delivered CSV for blister packing, carton packing, and H-PAC systems, enabling on-time qualification and production readiness.Lupin (Mandideep): Validated and qualified iFIX SCADA and servers, appreciated by client for proactive approach that supported successful go-live within prescribed timelines.