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Validation Specialist

Company: cyberThink, Inc.
Location: Bridgewater
Posted on: February 25, 2021

Job Description:

Title Validation Specialist Location Bridgewater, NJ-08807 Duration 6 months Client domain Biotech Local Independent resources are highly preferred Description Apply FDA and other applicable global health authority regulations to the development a competency in IT for computer systems supporting regulated business processes. Develop SOPs Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar. Develop and facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system. Review validation deliverables for projects Develop a competency in IT to perform CSV, assessments and ongoing change management Further develop and review computerized systems validation documents such as o Requirements Specification o Design Specification o CSV Risk Assessment o Test Plans o Test Summary Reports o Data Migration Plan o PrePost Executed Test Scripts o Traceability Matrix o Release to Production Statements Partner with QA Familiar with regulatory and inspection trends and advise the business on suitable action. Ability to create documents to an existing document standard. Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries. cyberThink is an EOE.

Keywords: cyberThink, Inc., Trenton , Validation Specialist, Other , Bridgewater, New Jersey

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