Roberta Bacchetta

Contact: [email protected] I am a pharmaceutical chemist, CTF, with a high expertise in quality topic and a deep knowledge of the manufacturing process of the pharmaceutical production, including sterile products. From 2020 focused on plasma and plasma derived products. Experience also in Regulatory and Pharmacovigilance areas. I have a strong communication skill and a wide knowledge in different areas from GMP complaince and computer validation, to regulatory and pharmacovigilance. I’m a team worker especially in cross functional structures. Native Italian, high fluency in English and Italian Specialties: Quality Assurance: Technical complaints, documentation system management, Corrective and Preventive Action (CAPA), Quality Inspection and Auditing, U.S. Food and Drug Administration (FDA), and Computer System Validation, Training either as planner or as trainer to the manufacturing people and now for marketing/sales people. Pharmacovigilance: adverse event handling, SOP management. Regulatory: maintain and update of the regulatory situation of either pharmaceutical products or cosmetics, biocides and dangerous goods. Expertise with all related regulations as Biocides, Cosmetics, CLP and REACH.