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Computer System Validation Specialist

Princeton, NJ

Posted: 03/06/2023 Job Number: 23275445

Job Description

Hybrid Work Schedule 50% Onsite.

Required Skills:
  • 2+ years of experience in managing the projects as CSV specialist /lead.
  • 2+ years of experience in testing, (script reviewing from a QA perspective in particular).
  • 2+ years of experience in authoring, reviewing various validation documentation such as (Val plan, Risk assessments etc.).
  • 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, 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.
  • Once trained, have the ability to work independently on CSV projects with minimal oversight.
  • Ability to perform in a highly matrixed organization structure.
  • 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.
  • Data Integrity experience is a plus.

Project Description:
  • 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.
  • Pre/Post 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 4+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: cambrose@alphaconsulting.Com


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Cheryl Ambrose

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