Validation EngineerPermanent
New Jersey, Parsippany - 07054Job Simplification
The announced job offer is made public by the firm: Intellectt Inc and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.
It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of New Jersey at the city Parsippany, in the country US - at this current ZipCode: 07054
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Job Overview
Position: Computer Systems Validation Engineer / CSV Business Consultant
Location: Parsippany, New Jersey (Remote)
Contract Duration: Long Term
Description:
We are looking for a Life Sciences Digital Quality and Compliance Senior Consultant, who has Experience in Life Sciences Industry, CSV, functional knowledge of Pharmaceuticals, Biologics, Medical Devices &
Diagnostics and FDA regulations, knowledge of analytics and reporting tools, strong communication skills, proficiency in MS Office suite.
Experience designing, implementing and operating IT risk management, IT quality and IT compliance activities in a life sciences organization, with particular focus on GxP, IT internal controls, SDLC management
Experience designing, implementing and navigating waterfall and agile SDLC (System
Development Life Cycle)
Experience in SAP/ERP Validation and test management
Experience leading IT risk, IT quality and IT compliance transformational programs
Experience in executing Change Control, and Document management
Experience with IT Quality Management Systems and CAPA management systems
Experience designing IT risk, IT quality and IT compliance operating models
Experience designing and implementing IT quality and compliance life sciences controls for cloud products
General IT strategy experience
Knowledge of IT systems, applications and tools required
Skills Needed:
6+ years working in the Life Sciences Industry
IT Risk, IT Quality and Compliance Management
Extensive knowledge of system development life cycle controls
Demonstrates a service-oriented leadership style
Knowledge of lean and risk-based process and service attributes
Employer Overview
Intellectt Inc
New Jersey, Parsippany - 07054- Agency