Thiago Giovannetti Email & Phone Number

• +10 years’ experience on Pharma on RA, QA, QC and pharmacovigilance;• Experience on Pharmaceutical drug importer setup (Office, Warehouse and Laboratory);• Specialized on Oncology Generic and Branded generic product registration;• +10 international ANVISA GMP inspection attended (Solids, injectable and biologic products);• +10 international GMP audit performed as lead auditor (as pre-audit and supplier qualification);• +50 National GMP audits performed as lead auditor (API, excipients, services, finished products and general parts) as part of supplier qualification;• ANVISA GMP High rate of inspection approval;• Key skills including Leader developer and teamwork enhancer;• Deep knowledge on technical documentation evaluation (BMR, stability studies, AMV, forced degradation, process validation, PDR, dissolution development report…);• Solid QMS implementation experience• ISO 9001:2015 audit and implementation experience;Accomplishments:At Camber Farmacêutica:• Office, warehouse and laboratory setup at Brazil in 6 months;• Fully implementation of QMS;• ANVISA GMP facility approvals;• Robust and complete ANVISA requirements diffusion to Heteto’s Team keeping both teams aligned to move forward;• First product registration approval.At Accord Farmacêutica:• Product release routine time improvement providing a quick access to market;• First Generic products registration (including Bortezomib) adding exclusive generic products to its basket making Accord more competitive at market;• Complete implementation of Accord’s pharmaceutical equivalence center – Equality;• Culture Implementation of deep technical dossier evaluation enhancing product registration.