Shrey Patel

A Computer System Validation (CSV) specialist with over 5 years of experience working across pharmaceutical, biotech and regulated industries. My background includes deep knowledge of 21 CFR Part 11, GxP, FDA, and Health Canada regulations, along with extensive hands-on experience qualifying lab systems, validating software (GAMP Category 4 & 5) and leading successful audit-readiness initiatives. As the Computer System Validation Specialist (Hardware & Software) at API, I support validation, risk assessment and compliance for applicable software and instrument systems. I hold a Bachelor’s degree in Electrical Engineering and have worked with Pharmaceutical companies like Grifols, Alembic, Zydus, Aspen and Lupin. I take pride in my strong documentation practices, regulatory insight and ability to manage complex validation lifecycles from planning through execution.