The auditor, an Italian professional, boasts over 30 years of experience in the life sciences sector, initially focusing on chemical synthesis and industrialization. Their career evolved into roles such as Quality Director and Qualified Person, overseeing GxP compliance and regulatory adherence in pharmaceutical, medical device, and cosmetic companies. They've managed projects like plant construction, quality system implementation, and validation processes. With a vast auditing background, they've conducted around 300 audits across various GxP and ISO standards. Their expertise spans EU and USA regulations, and they hold certifications as a Responsible Person under MDR 2017/745 and a Qualified Auditor for ISO standards. Proficient in multiple languages, they bring a comprehensive skill set to ensure compliance and quality in the life sciences industry.