Gira Patel

Background

About Gira Patel

I’m a Quality Assurance Associate with a Master’s in Pharmaceutics and hands-on experience in GMP-regulated pharmaceutical operations. I specialize in batch record review, deviation tracking, CAPA documentation, SOP compliance, and audit readiness ensuring full alignment with FDA 21 CFR Part 11 standards. My background includes supporting IQ/OQ/PQ validation protocols, reviewing sanitation and calibration records, and maintaining controlled documentation for quality systems. I’ve trained under aseptic conditions in ISO-classified environments and understand the importance of precision and compliance in both sterile and non-sterile manufacturing settings. Known for my attention to detail and cross-functional collaboration, I bring a strong commitment to quality, regulatory compliance, and patient safety. I’m actively seeking long-term opportunities in QA, QC, or validation roles within pharmaceutical, biotech, or CDMO organizations. Core Skills: • GMP & cGMP Compliance | FDA 21 CFR Part 11 | Audit Readiness • Batch Record Review | Deviation & CAPA Management | SOP Compliance • Validation Support (IQ/OQ/PQ)| Logbook Review | Documentation Control • ISO Cleanroom Training | Aseptic Practices | Quality Risk Management • Tools: Excel | Document Management Systems | SAP (Basic)