Sharon Yarkoni
Head of global QA at ImPact Biotech- Claim this Profile
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Bio
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Experience
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ImPact Biotech
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Australia
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Biotechnology
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Head of global QA
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Nov 2022 - Present
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Dot Compliance
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United States
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Software Development
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100 - 200 Employee
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QA Director
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Jul 2019 - Nov 2022
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Dexcel Pharma
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Israel
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Vendors QA Manager
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Nov 2016 - Jul 2019
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MediWound
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Israel
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Pharmaceutical Manufacturing
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1 - 100 Employee
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QA Project Manager
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Mar 2015 - Nov 2016
In my role as QA project manager I am responsible for all QA activities within the organisation. I am responsible for MRB/CAPA/Deviations/Change requests quality systems. I have Vast experience with Good Clinical Practice, supporting all R&D and clinical trials requirements.as well as Good Manufacturing practice supporting all commercial manufacturing activities supporting the supply of product to the EU,US and ROW. Approval and Release of Final product and RM, Writing and approving of Validation Protocols& reports, Writing QA/Technical SOP’s. supporting all quality system requirements, such as deviations/complaints investigations, Change controls and CAPA's. Review & Approve of all technical & engineering documents, Suppliers/contractors audits. Contact with Health Authorities, Handling of complaints/Recalls, Accompanying Health Authorities Audits. Control of Documentation Center, QA support for clinical studies, QA support for production activities Responsibility and Ownership of all IT software related to quality assurance, SAP, Priority, Trackwise, PLM, Origin, React, Lims etc. Show less
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Omrix Biopharmaceuticals
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Belgium
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Wholesale
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1 - 100 Employee
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External Manufacturing QA manager
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Sep 2013 - Mar 2015
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QA Manager JP plant
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Jun 2012 - Sep 2013
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Supplier Quality Group Manager
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Nov 2010 - Jul 2012
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QA Team Leader
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Mar 2010 - Nov 2010
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QA Supervisor
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Nov 2007 - Mar 2010
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Education
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Bar Ilan university
Master's degree, Logistics, Materials, and Supply Chain Management -
Bar Ilan university
Bachelor of Science (B.Sc.), Biology, General