Cristina Aparecida Diagone Fontana de Souza

Bachelors degree in Chemistry from the Institute of Chemistry (IQSC) at the University of São Paulo, with a masters degree in Physical Chemistry and a Ph.D. in Analytical Chemistry from IQSC. Holds an MBA in Production Engineering from UFSCAR and completed undergraduate research in Organic Chemistry at IQSC. Previously a researcher at IFSP São Carlos Campus in the Optics group, developing spectroscopic methods for agricultural applications. Currently a technical researcher and scholarship holder in the development of analytical techniques focused on the food sector (coffee) at OptikAI. Experienced in laboratory management and technical supervision of analytical laboratories, specializing in method development and validation, as well as quality control across various sectors, including pharmaceuticals (human and veterinary), food, cosmetics, environmental, agrochemicals, and herbal products. Proficient in analyzing a wide range of matrices (environmental, pharmaceuticals, cosmetics, agrochemicals, etc.) using techniques such as Ultraviolet and Infrared Spectroscopy, Nuclear Magnetic Resonance (NMR), Dynamic Light Scattering (DLS), High-Performance Liquid Chromatography (HPLC) with Diode Array Detector (DAD), Ion Chromatography, Mass Spectrometry (MS, MS/MS), Gas Chromatography (GC) with MS, FID (Flame Ionization Detector), FPD (Flame Photometric Detector), and ECD (Electron Capture Detector), ICP, Atomic Absorption, Karl Fischer Titration, Titrimetry, Colorimetry, and Gravimetry. Expertise in Solid-Phase Extraction (SPE), Solid-Phase Microextraction (SPME), and Liquid-Liquid Extraction (LLE). Experienced in analytical validation according to matrix-specific regulations, including RDC 166/2017, ICH guidelines, DOQ-GCRE-008 (INMETRO), and PNCR guidelines for residue depletion studies. Skilled in extractables and leachables studies in packaging, photostability and forced degradation studies for cosmetics and pharmaceuticals (human and veterinary), pharmaceutical equivalence, bioequivalence, batch similarity, analytical and bioanalytical method validation, and quality control (physicochemical assays for pharmaceuticals and nanoparticles). Previously served as a Technical Responsible professional for accreditation, control, and regulatory agencies (CRQ, Anvisa, MAPA, Inmetro). Held roles as Study Director and Test Facility Manager, ensuring compliance with Good Laboratory Practices (GLP) in pharmaceuticals and agrochemicals. Possesses 25 years of experience in analytical method development, quality control, and quality assurance (ISO 17025 and GLP), including laboratory management, standard operating procedure (SOP) development, training, technical protocol creation, auditing/inspection, scientific reporting, and implementation of new laboratory scopes and business areas. Extensive experience in regulatory affairs and studies for the development and registration of pharmaceuticals and agrochemicals. Accredited inspector by Inmetro for GLP compliance assessments in analytical laboratories and companies. Comprehensive knowledge of key regulations, resolutions, and guidelines governing pharmaceuticals, agrochemicals, cosmetics, veterinary products, and environmental sectors. Proficient in financial feasibility studies for implementing and expanding projects of various natures (cost reduction, productivity gains, process optimization, synergies, and new services), as well as business strategy and sales in the veterinary products, pharmaceuticals, and agrochemicals sectors. (Source: Lattes Curriculum)