Nayan Patil
Consultant-Risk & Regulatory Advisory – EY | Quality & Compliance Specialist | CSV | GAMP 5 | 21 CFR Part 11 | Life Sciences | ERP Validation
- Role
- Consultant - Computer System Validation at EY
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Nayan Patil
Consultant in Computer System Validation (CSV) at EY with 6+ years of experience…
Experience
Consultant - Computer System Validation
Dec 2022 — Present · Pune, IN
As a Consultant in EY’s Risk Advisory practice, I assist leading pharmaceutical and biotech clients in achieving regulatory compliance and operational excellence through robust Computer System Validation (CSV), Quality Risk Management, and Data Integrity initiatives.Key Contributions:Led validation and compliance readiness assessments for ERP systems, Manufacturing, and Quality Control systems ensuring alignment with 21 CFR Part 11, EU Annex 11, and GAMP 5 requirements.Led document authoring and review process for Validation Documents across critical systems.Executed comprehensive remediation activities post-assessment, addressing identified gaps in electronic records, audit trails, access controls, and system validations.Interfaced with QA, IT, and system owners to work on Discrepancies & CAPADelivered end-to-end validation documentation.Managed greenfield qualification projects in pharma manufacturing environments, including equipment, utility, and software validations.Utilized Automated Validator Tool to streamline documentation, enhance traceability, and reduce validation cycle times.
Education
Dr. Babasaheb Ambedkar Technological University
Instrumentation Engineering
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