Larisa Primak has extensive experience in various roles related to business information systems (BIS) quality, quality assurance, validation, and compliance in the pharmaceutical and biotech industry. Larisa has worked for several companies, including argenx, Epizyme, Insulet Corporation, Biogen, Sanofi Genzyme, Genzyme Corporation, and Speedline Technologies, Inc. Larisa's responsibilities have included leading improvement initiatives for BIS processes, providing support for computerized systems, overseeing validation of GxP systems, managing and administering QMS related deliverables, conducting IT governing SOPs assessments, and providing compliance and validation support for IT automation projects. Throughout their career, Larisa has demonstrated expertise in documentation management, system testing, risk assessments, and change management.
Larisa Primak has a Bachelor of Science degree in Electronic Engineering from Ukraine State Politechnic University, which they obtained from 1986 to 1990. In addition, they have completed various professional courses in Information Technology Project Management, Oracle EBS Management, QAD ERP Management, and JavaScript & C Programming from institutions such as Boston University Corporate Educational Center, Oracle Corporation, PROGRESS Software Technical Institute, and Northeastern University.
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