Ticino, Switzerland
Director, Corporate Quality Compliance, Risk Management & Continual Improvement
Pharmaceuticals
Education
AIFA- Aknowledgement as Qualified Person 2007 — 2007
Qualified Person certification, Pharmaceuticals
Università degli Studi di Bari 1992 — 1996
Clinical Pathology, Applied biology and Medicine
Università degli Studi di Bari 1992 — 1993
Qualification, Biologist practice qualification
Università degli Studi di Bari 1984 — 1992
Bachelor, Biology
Experience
PDA Italy Chapter January 2015 - Present
PDA - Parenteral Drug Association January 2003 - Present
Bracco April 2014 - Present
Bracco October 2014 - March 2015
Merck Group April 2013 - March 2014
Merck Group October 2011 - March 2013
Nerviano Medical Sciences 2011 - 2011
Nerviano Medical Sciences 2011 - 2011
Novartis 2008 - 2011
Janssen-Cilag, a subsidiary company of Johnson&Johnson March 2008 - September 2008
Skills
Aseptic Processing, Technology Transfer, GLP, Clinical Development, GMP, Quality System, V&V, Vaccines, GCP, Trackwise, Compliance, Cleaning Validation, Quality Systems, GxP, SOP, Pharmacovigilance, Quality Assurance, Training, Medical Devices, LIMS, Regulatory Submissions, ISO 13485, ISO, FDA, Iso 9000, R&D, Microbiology, Validation, Certified Green Belt, Pharmaceutical Industry, Pharmaceutics, Quality Management, Biotechnology, FDA GMP, CRO, Clinical Trials, Regulatory Requirements, Change Control, Computer System..., Pharmaceuticals, Drug Development, Auditing, CAPA, Quality Auditing, Sop, 21 CFR Part 11, Regulatory Affairs, HPLC, ICH-GCP, Analytical Chemistry