Ayan Ghosh

About Ayan Ghosh

GxP Compliance Lead with over 5 years of specialized experience in validating computer systems deployed across the Life Sciences domain, including pharmaceutical, biotechnology, clinical research, and medical device environments. Strong command of global regulatory requirements and industry best practices, with a proven track record of leading complex validation projects and ensuring compliance with GxP standards.Led multiple customer engagements independently, managing end-to-end compliance and delivery of validation projects. Responsible for overseeing cross-functional teams of 8–10 validation professionals and leads, providing strategic guidance, mentoring, and technical oversight. Ensures that all deliverables meet regulatory expectations and align with both customer and internal quality processes.Possesses deep expertise in CSV and CSA, with hands-on experience in developing comprehensive validation packages for scientific vendor applications, including validation plans, qualification scripts (IQ/OQ/PQ), risk/impact assessments, traceability matrices, and summary reports. Expert in risk-based validation and lean documentation, ensuring systems are always audit-ready. Strong foundation in R&D, manufacturing, and clinical operations. Provides expert-level review and direction on documentation including URS, FRS, qualification protocols, test results, risk assessments, data integrity evaluations, SOPs, and deviation reports.Well-versed in global regulations such as 21 CFR Part 11, EU Annex 11, HIPAA, GDPR, CLIA/CAP, PIC/S, and Japanese ERES. Additionally, has authored compliance reports aligned with international regulations such as 21 CFR Part 11, EU Annex 11, HIPAA, GDPR, PIC/S, and Japanese ERES.Technically proficient in ELNs, LIMS, and automation testing tools such as TestCafe, Selenium, Eggplant, and Robot Framework. SME for script creation using TestCafe Studio across multiple projects, contributing to automation validation processes and enhancing testing efficiency.Combines strategic leadership with hands-on expertise to deliver compliant, efficient, and high-quality validation outcomes in regulated environments.

Experience

1. Gxp Compliance Lead

   Zifo

   Apr 2025 — Present · Chennai, IN

   GxP Validation and Regulatory Consultant, experienced in managing multiple customer engagements across the life sciences sector, ensuring end-to-end regulatory compliance and successful project delivery. Led and mentored teams of 10+ validation professionals, providing strategic direction, technical oversight, and fostering a culture of quality and accountability.Overseeing of a full validation lifecycle—planning, execution, and documentation—ensuring alignment with global regulatory standards and client expectations. Deep knowledge of 21 CFR Part 11, EU Annex 11, HIPAA, GDPR, CLIA/CAP, and apply best practices from ISPE GAMP, FDA Data Integrity guidance, GDP, and CSA methodologies. Primary responsibilities include expert review of URS, FRS, validation plans, risk and regulatory assessments, IQ/OQ/PQ protocols, traceability matrices, deviation reports, SOPs, and summary reports.

Education

• Jadavpur University

  Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences