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Work experience

May 2012Present

Quality Assurance Specialist

Farmigea S.p.A.
• Change Management: - Application of a structured methodology to execute change management activities; - Identify, analyze and assess the change impact; - Coordinate activities, deadlines, solve conflicts, track and report issues; - Support communication and training efforts; - Define and measure success metrics and monitor change progress. • CAPA system Management: - Identification of CAPA according to QA Manager; - Coordinate activities, deadlines, solve conflicts, track and report issues; - Define and measure success metrics and monitor CAPA progress. • Process Validation: - Validation Protocol and Report, development and review. • Support to the development and maintenance of quality procedures, and systems related to Quality Assurance oversight.
Nov 2011May 2012

International Regulatory Affairs Assistant

Farmigea S.p.A.
• Applications for new registrations, variations; • Support to the registration activities outside Europe (Middle-East/North Africa area).
Jun 2010Oct 2011

Molecular Biologist

CNR - Consiglio Nazionale delle Ricerche
• Project Development; • Mutational screenings; • Molecular modeling.

Education

20112012

II level Postgraduate Master's Diploma in Regulatory Affairs and Pharmaceuticals Technologies

University of Pavia
Legislation in the field of Marketing Authorization and related activities (applications for new registration, variation); pharmacovigilance; and cGMP quality management system, quality control system, departments and production processes of the pharmaceutical industry and relevant legislation; patents; research and development; technologies of dosage forms of new generation.
20092011

Master's degree in Bio-molecular Technologies

University of Pisa
SMC1A mutational screening in Human Colorectal Cancer. Principal activities covered: DNA and RNA extractions, PCR, real-time PCR, Molecular modeling.
20042008

Bachelor's degree in Molecular Biology

Università degli Studi di Lecce
Mitochondrial citrate carrier functional characterization in Drosophila melanogaster mutant strain EP(3)3364. Principal activities covered: Protein extraction, Western Blot, ImmunoBlot, Purification, Reconstitution, and Transport studies.