Pharmaceutical Quality Assurance management and specialist with expertise in FDA CGMP and GLP regulations, ICH, EudraLex Volume 4 GMPs. QA specialist who developed and implemented successful Quality Management systems including non-conformance, OOS, CAPAs, CAPA effectiveness, change management, risk management, auditing, and training programs. Built, trained, and lead an effective QA team. Demonstrates professionalism, creativity, resourcefulness, and competence in managing day-to-day QA activities in support of company goals. Decisive and direct, yet flexible in responding to constantly changing assignments.Exhibits keen organizational and problem-solving skills, with proven ability to coordinate multiple projects and meet deadlines under pressure. Adept at communicating effectively with staff at all levels of authority. Proficient with Microsoft Office Suite, SharePoint, Kaizen Training Manager, Microsoft DynamicsSpecialties: Quality System Management - Documentation, Change Management, Non-conformance, Root Cause Analysis, CAPAs, Complaints • Auditing - Audit Plan • Compliance Audits • Internal Audits • Supplier Audits/Evaluations • Laboratory Compliance Audits • GMP Process Validation • Method Validation/Review • Regulatory Compliance - 21 CFR 58, 210, 211, 11 • OECD, ICH Q7, ICH Q9, ICH Q10, EudraLex Vol 4 GMP • Interpreting Regulations • Regulatory Affairs