Oshra Hilemsky, B.Sc., Bio-MBA

Pharma Quality Project Manager

Over 15 years of experience in the sterile pharmaceutical industry under GMP conditions. Management of microbiology section in leading pharmaceutical company, including microbiology laboratory, environmental monitoring and compliance teams. Knowledge in regulatory requirements for clean rooms, aseptic processing, environmental monitoring and microbiology laboratory analytical methods. Experience in EM and microbiology deviation investigation, CAPA implementation and quality improvement projects. Experience in internal and external quality audit – participating and accompanying customers in regulatory audits (FDA, EMA, IMOH etc.). Performing mock audits, gap analysis for aseptic processes, writing and updating contamination control strategy (CCS).