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Computer Systems Validation Specialist - Junior to Mid Level

Company: Alpha Consulting Corp.
Location: Trenton
Posted on: November 23, 2020

Job Description:

COMPUTER SYSTEMS VALIDATION SPECIALIST - JUNIOR TO MID LEVEL PRINCETON, NJ Required Skills 3 years of IT Validation 3 years of SAP 3 years of 21 CFR Part 11 3 years of HPALM 3 years' experience Follow SOPs and industry best practices Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar. 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. Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.) application development and lifecycle management (e.g. HP ALM, JIRA, etc.) and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc.). Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members. Ability to perform in a highly matrixed organization structure. Project Description 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 which are contracted to third party suppliers Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues Assist in planning, implementing, and documenting user acceptance testing Review computerized systems validation documents such as Requirements Specification Design Specification CSV Risk Assessment Test Plans Test Summary Reports Data Migration Plan PrePost Executed Test Scripts Traceability Matrix Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data or the system. Obtain and respond to QA review Participate in establishing standard quality and validation practices. Independently assess compliance practices and recommend corrective actions Approve validated computer system related change requests. Monitor regulatory and inspection trends and advise the business on suitable action. This month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl mailto ALPHA'S REQUIREMENT 20-01805 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE ZR

Keywords: Alpha Consulting Corp., Trenton , Computer Systems Validation Specialist - Junior to Mid Level, Other , Trenton, New Jersey

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