Validation Specialist at NTT DATA Services in Princeton, NJ

NTT DATA Services

Princeton, NJ
October 27, 2020
FULL TIME
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Validation Specialist

Computer System Valdiation ( CSV ) Princeton, NJ Contract Opening " 3 years experience in Computer System Validation " 3 years of ALM " 3 years of CSV Documentation author and review, approve " 1-2 years of experience in Change Control " Should be able to work with minimal supervision Nice to have Experienceunderstanding of Data Integrity concepts Understanding of GAMP categories and validation approaches Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes 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.
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 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.
Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
Experience with electronic document management systems (e.g. documentum, Qumas, Share.
Point etc.) application development and lifecycle management (e.g. Client 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.
Once trained, have the ability to work independently on CSV projects with minimal oversight.
Ability to perform in a highly matrixed organization structure The Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.

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Job Expires: November 26, 2020

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