Kathleen Brady Email & Phone Number

Accomplished member of Regulatory Affairs and Quality unit with 20+ years combined experience in Regulatory Affairs, Quality Control and Quality Assurance in the pharmaceutical industry. BS degree in Chemistry and Master's Degree in Business Administration with concentration in Management and Leadership. Experienced in cGMP setting, FDA 21 CFR, GLP, ICH, EU GMP, regulatory submission, stability program, investigations, analyzing quality issues, designing improvement, developing plan for corrective and preventative measures (CAPA), monitoring compliance, statistical analysis, product profiling, developing policies/procedures, auditing suppliers, and managing QMS. • Regulatory submission • Hosting audits• Auditing suppliers • Strong problem solving skills• Managing QMSADDITIONAL RELEVANT EXPERIENCES:USP (US PHARMACOPEIAL CONVENTION)Baltimore, MarylandGood Documentation Guidelines Expert Panel PITTCONPhiladelphia, PennsylvaniaShort Course Instructor ILLINOIS INSTITUTE OF TECHNOLOGYGuest Lecturer CERTIFICATION:Certified Quality Auditor by American Society for Quality (ASQ)

Listed skills include Fda, Capa, Gmp, Validation, and 15 others.