Position Overview
Roles & Responsibilities:
Prior JNJ TQ Experience a must
Experience in validating QMS and different modules in QMS
+ years' experience with System Development Lifecyle + years' experience in Computer System Validation (Based on the role selected)
Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Experience with QMS, including giving guidance when a Non-Conformance has occurred on a system.
Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance Plans, test protocols, Test Summary reports and Compliance Reports
Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.