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Computer Systems Validation Specialist - (Junior to Mid Level with 3-5

Company: Alpha Consulting Corp.
Location: New Brunswick
Posted on: August 23, 2019

Job Description:

COMPUTER SYSTEMS VALIDATION SPECIALIST - (JUNIOR TO MID LEVEL WITH 3-5 YRS EXPERIENCE) NEW BRUNSWICK, NJ Required Skills:

  • 5+ years of Computer system validation.
  • 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.
  • Advanced knowledge of MS Office and Visio.
  • GMP (Good Manufacturing Practices) is a plus.
  • 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. 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.
      • 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.

        This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: ALPHA'S REQUIREMENT #19-01444 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #ZR - provided by Dice

Keywords: Alpha Consulting Corp., Wayne , Computer Systems Validation Specialist - (Junior to Mid Level with 3-5, IT / Software / Systems , New Brunswick, New Jersey

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