I am Bachelor of Pharmacy (2002), Master in Pharmaceutical Sciences (2005 – Pharmaceutical Process Development) and Doctor in Pharmaceutical Sciences (2009 – Quality Risk Management), all awarded by University of Sao Paulo (Brazil). I am also Bachelor of Pedagogy/Education (2012) awarded by Federal University of Sao Carlos (Brazil).
17 years of relevant experience in Quality Assurance, working for pharmaceutical companies, such as Janssen-Cilag (Johnson & Johnson Group); DLA Pharmaceutical (sterile pharma business of Dentsply Group), where I worked as Quality Manager (QA and QC), being in charge of Quality Budget, Key Performance Indicators, auditing the Quality System (internal and suppliers), contact person to Regulatory Bodies, harmonization of the internal documents with international guidelines such as ICH, PICS and Pharmacopeias, Regulatory Affairs, Training in Quality (Good Manufacturing Practices, Good Laboratory Practices, ISO 9001:2000 and ISO 13485:2003),and, for FURP, which is a Pharmaceutical Industry run by Sao Paulo State Government in Brazil, where my main tasks were related to cleaning validation, software validation, performance qualification and GMP training and audit support for supply chain. Nowadays, I still work at FURP, however I assumed a new task: I was nominated to be Auditor for the Public-Private Partnership Agreement. This Agreement is budgeted around R$ 2,6 billion and the scope of auditing is related to regulatory compliance, performance assessment, regulatory affairs/portfolio. In partnership area, in 2017 I was in charge of writing and presenting orally to the Health Ministry the executive projects of products that should be objective of a technology transfer to the company I work from a private company and sold to Health Ministry.
10 years of teaching experience, working as invited professor and/or coordinator of Postgraduate courses, being in charge of redesigning the curriculum and teaching classes on Quality Audit, Quality Management, Regulatory Affairs, Logistics and Health Care Management.
3rd pillar: Since 2012, experience in a standard-setting organization (U.S. Pharmacopeia Headquarters, in Rockville, MD, USA), working as Visiting Scientist for 6 months, in a hands-on, highly technical position, being in charge of writing the draft of 5 chapters on Good Distribution Practices, being in frequent contact with Scientific Liaisons and Expert Committee Members. After this work, I was nominated to participate as Expert in two other USP Panels related to Good Distribution Practices and Clinical Trials Materials and in 2015 I was nominated for 2015-2020 new cycle as USP General Chapters - Packaging and Distribution Expert Committee Member. I am a Subcommittee Co-Chair, that is in charge of reviewing the General Chapter <1079> that talks about Storage and Transportation of Drug Products. In 2013 and 2017 I was speaker in ANVISA in a workshop organized by USP Pharmacopeia Education on Packaging and Distribution. Also in 2017 I was speaker of USP-APEC Center of Excelence in Supply Chain.