Verified recordProfessional Services

Nayan Patil

Consultant - Computer System Validation at Ey

Based in Pune, India

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Seniority

Staff

Department

Other

Location

Pune

Industry

Professional Services

Company size

394K

Contact information

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n•••••••@••••••.com

Phone

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+91 ••• •••• ••••

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Background

About Nayan Patil

I’m a passionate and detail-oriented professional with 5+ years of experience in Computer System Validation (CSV), Quality Management Systems (QMS), GxP audits, and regulatory compliance across pharma, biotech, and life sciences sectors. At EY, I lead risk consulting and validation projects involving SAP, LIMS, SCADA, BMS, and EMS platforms — ensuring full alignment with 21 CFR Part 11, EU Annex 11, and GAMP 5. I’ve delivered validation and compliance solutions for greenfield projects, remediation, and regulatory readiness. Core Strengths: 21 CFR Part 11 & Annex 11 Compliance SAP System Validation (MM, SD, PP, QM) LabWare LIMS, EMS, EDMS, BMS Systems Data Integrity, Risk Assessment & CAPA, Deviation Handling I thrive in cross-functional teams, love solving complex compliance challenges, and aim to continuously elevate regulatory maturity for my clients.

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