Moneesha James

I've supported GxP computerized systems in regulated biopharmaceutical environments for more than seven years, with a focus on software quality, computer system validation, and audit-ready documentation.

At Genentech, I provided independent QA oversight for validation documentation across multiple projects. I reviewed Validation Plans, Risk Assessments, URS/FRS, IQ/OQ/PQ protocols, traceability matrices, and summary reports against 21 CFR Part 11, GAMP 5, and internal quality standards.

Previously at Gilead Sciences, I performed post-execution protocol reviews, managed change controls in TrackWise QMS, and maintained validation records in EDMS. I also authored and reviewed controlled documents, supported audits, and partnered with business users on SOP and system-documentation updates.

My biotechnology background includes research experience at Sangenomics Research Labs, where I supported project design, testing, reporting, specimen preparation, and laboratory data analysis.