Work History

Work History
May 2012 - Present

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 2011 - May 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 2010 - Oct 2011

Molecular Biologist

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

Education

Education
2011 - 2012

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.
2009 - 2011

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.
2004 - 2008

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.