Michele C.

Michele C. has a diverse work experience in various roles and industries.

From 2013 to 2020, Michele worked at Novartis in different positions. As a QA CSV - Data Integrity Officer, they ensured compliance of plant computerized systems with GMP regulations and reviewed technical documentation related to these systems. As an e-Compliance CSV Officer, Michele oversaw periodic reviews of the validation status of GMP-relevant computerized systems and managed any compliance gaps.

In 2020, Michele joined Aizon as a Senior QA Engineer and later became the GxP Compliance Validation Package Owner.

Currently, Michele is working at PQE Group as a Project Manager, CSV/CSA & Data Integrity Expert. Michele manages projects, coordinates consultants, and reviews validation deliverables before client delivery.

Prior to their pharmaceutical and IT roles, Michele worked as a Tutor for the B.Sc. and M.Sc. course in Computer Science at the University of Bologna and had an internship at SAC - SOCIETA' AEROPORTO CATANIA SPA.

Michele C. completed a Master of Science (M.Sc.) in Computer Science at Alma Mater Studiorum – Università di Bologna from 2011 to 2014. Prior to that, from 2006 to 2011, Michele earned a Bachelor of Science (B.S.) in Computer Science from Università di Catania. Michele's secondary education was completed at Liceo Scientifico G.Galilei - Catania from 2001 to 2006, where they focused on P.N.I. (National Computer Science Course).

In addition to their academic education, Michele also obtained several certifications. They attended a seminar on Validation and 21CFR Part 11 Compliance of Computer Systems presented by Angela Bazigos from GlobalCompliance Panel in May 2014, and obtained a Certificate of attendance. In the same year, Michele also completed a training program in Professional Designation in Computer System Validation, Prover Documentation Practices, and received a Certificate of training completion for 21 CFR Part 11 from BioPharma Institute.

In 2016, Michele obtained a Certificate of attendance for the Data Integrity Advanced Course from Novartis. Recently, in March 2019, Michele obtained certificates of attendance for the ECA - Audit Trail Review and ECA - Data Integrity courses from ECA - European Compliance Academy. Lastly, in March 2005, Michele obtained the E.C.D.L. (European Computer Driving Licence) from AICA - Associazione Italiana per l'Informatica ed il Calcolo Automatico.