Vraj Patel Email & Phone Number

Driven by a commitment to excellence in pharmaceutical and biologics manufacturing, I specialize in quality engineering, regulatory compliance, and process validation. With expertise in managing quality systems under ISO 13485, 21 CFR 820, and ICH guidelines, I have worked on risk assessments, change control, and impact evaluations to ensure seamless product lifecycle management.From creating cGMP-compliant validation plans and conducting FMEAs to streamlining quality processes with tools like TrackWise, Minitab, and Dassault - BIOVIA Discoverant, I’ve consistently delivered operational efficiencies and enhanced compliance. My hands-on experience includes managing regulatory dossiers, conducting process optimizations, and supporting global submissions for biologics and injectables.Let’s connect if you’re passionate about driving innovation and quality in healthcare manufacturing!