Ms. Guven over 20 years of experience in IT Quality and Computer Systems Validation in Pharmaceutical Industry at Apotex including: Process / Continuous Improvement experience, superior knowledge on FDA 21 CFR Part 11 Electronic Records and Electronic Signatures and Data integrity remediation.
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 10,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development.
Continuous learning and improvement is a driver in my job. The technology is changing and very dynamic. I love my job as adapting new methods and technologies into Computer Systems Validation excites me.