14 years of experience in the sterile pharmaceutical industry under GMP conditions. Knowledge in quality management systems – CAPA, Change Control and Deviation. Knowledge in regulatory requirements for clean rooms, aseptic processing, environmental monitoring and microbiology laboratory analytical methods. Experience in EM and bioburden deviation investigation, CAPA implementation and quality improvement projects. Experience in internal and external quality audit, leading mock audit and managing a gap analysis process for the aseptic filling department. Participation in regulatory audits (FDA, EMA, IMOH etc.).
B.Med.Lab.Sc, Medical Laboratory Science | Ben-Gurion University of the Negev
Bio-M.B.A, M.B.A. with specialization in Bio-Medical Management | The College of Management Academic Studies