#11613 - CSV Engineer

Description

Qualitest is the world’s leading AI-Powered Quality Engineering Company.

We bring in the culture of quality orchestration, technology, and operational landscape through our engineering-led, process discipline.

We provide innovative and scalable business quality engineering solutions that protect our client’s brand through end-to-end value demonstration with a laser focus on customer experience and release velocity. This year we are celebrating 25 years of innovation and excellence.

Every day with Qualitest is an opportunity to innovate, grow and change.

We’ve assembled one of the largest, most talented groups of creative, critical problem-solvers in the world with over 7000 engineers.

Talented, intelligent, and passionate people have made Qualitest the world’s leading Quality Engineering company. If you want to learn from the best, there’s no better place to start!

We’re seeking a CSV Engineer to join our team in Kfar Sava and Netanya!

Responsibilities

• Write Computerized systems validation documents and test protocols:IQ,OQ,PQ
• Write Computerized systems design and summary documents: URS,FRS,VP,VSR
• Write software applications reject lists, bug identification, report and monitoring.
• Functional and detailed documented testing of life-science computerized systems.
• Comply with healthcare regulation for computerized systems ( 2CFRPART11, CE Annex 11)
  
  

• BS.c in Biology/Chemistry/Biomedical Engineering or related field- MUST
• 1 year of experience in quality assurance in the pharma industry
• Experience with IT technical issues.
• Experience in computerized system validation in the life science industry( Biotech, Pharma, Medical Device etc.)
• English- very high level
  
  

• Have continuous access to and work with Senior Specialists and Practice Experts
• Be a part of a leading company, globally recognized as a Visionary by Gartner Magic Quadrant
• As a global company, we offer unique placement opportunities around the world
• Never stop experimenting and learning with Qualitest Tech academy: training courses, mentorship programs, technical tribes, sponsored certifications, leadership programs and much more
  
  

• Visit our website at www.qualitestgroup.com
• Check out our Career page:https://qualitestgroup.com/careers/open-positions/