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Esra Guven, BScEE, PMP, SSGB

Associate Director, GIS-Computer Systems Validation

Apotex Inc.

Country or State

Canada

Bio

• Over 20 years of experience in the area of IT Quality and Computer Systems Validation in Pharmaceutical Industry • Over 15 years of management, leading and mentoring experience • Over 15 years of Process / Continuous Improvement experience • Superior knowledge on FDA 21 CFR Part 11 Electronic Records and Electronic Signatures and Data integrity remediation • Project Management Institute (PMI) Project Management Professional (PMP) certified • American Society of Quality (ASQ) – Certified Six Sigma Green Belt • Certified Trainer • Certified Lead Investigator

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Current Position

Associate Director, GIS-Computer Systems Validation at Apotex Inc.

Degrees

BSc, Bachelor of Science Degree (Electronics Engineering)

Skills