Edit Szőcs is a highly experienced senior pharmaceutical quality professional and MSc Chemical Engineer with more than 35 years’ experience across pharmaceutical manufacturing, health authority inspection, global GMP/GDP auditing and regulatory compliance consultancy. She brings a rare combination of hands-on industry leadership, former European Health Authority inspection experience and extensive international audit delivery, enabling her to provide practical, risk-based and regulator-aligned advice to pharmaceutical, biotechnology and supply chain organisations.
Expert in GMP/GDP compliance, inspections, quality management systems, CAPA, data integrity, risk management, supplier qualification, distribution chain compliance and GxP training.
Conducted more than 100 GMP/GDP inspections and audits worldwide, including more than 20 WHO prequalification inspections as Co-Inspector.
Hosted and supported more than 50 Health Authority inspections, including 25 FDA inspections, providing strong insight into inspection readiness and remediation.
Held senior quality assurance and production leadership roles in Canada from 1990 to 2011, overseeing GMP operations across multiple dosage forms.
Served as Senior Expert within a European Health Authority from 2011 to 2016, contributing to GMP inspection programmes and regulatory interpretation.
Collaborated with WHO, PIC/S and EMA, and served as a member of the PIC/S Risk Assessment Expert Circle and Advisory Board of the European QP Association.
Since 2016, has worked as a Senior GMP/GDP Auditor and Consultant for Ares Trading, Merck Switzerland and as an Independent Consultant supporting GxPAssure Limited.
Delivers global audits across manufacturing, warehousing and distribution, with reports aligned to EU, Swiss, US FDA and local regulatory expectations.
Product expertise includes sterile and non-sterile pharmaceuticals, IMPs, biotechnology products, APIs, biologics, monoclonal antibodies and antibody-drug conjugates.
Technical experience spans solid and liquid dosage forms, sterile fill-and-finish, lyophilised and combination products, synthetic APIs and commercial production.
Strong knowledge of large-scale fermentation and quality control testing using classical chemistry and advanced techniques including UHPLC, GC, MS and NMR.
Delivered training and technical presentations to regulatory audiences, including FDA Inspectors on behalf of PIC/S and Swissmedic Inspectors.
