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Computer Systems Validation Specialist

Company: Alpha Consulting Corp.
Location: New Brunswick
Posted on: October 26, 2018

Job Description:

COMPUTER SYSTEMS VALIDATION SPECIALIST NEW BRUNSWICK, NJ Required Skills:

  • 6+ years' experience.
  • Experience in producing software documentation and business requirement documentation (minimum 3 yrs.); experience with Software Development Life Cycle Management and CFR 21 Part 11 compliance.
  • Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
  • Ability to create documents to an existing document standard.
  • Working knowledge of Documentum.
  • Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
  • Able to develop all documentation required for a 21/11 validated project, including Validation Plans and Summaries. Project Description:
    • Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes.
    • Follow SOPs and industry best practices.
    • Conduct training on good documentation and good testing practices.
    • 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.
      • Prepare validation summary and test summary reports.
      • 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 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: ALPHA'S REQUIREMENT #18-01546 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE - provided by Dice (COMPUTER SYSTEM VALIDATION OR CSV ) AND(PHARMACEUTICAL COMPANIES ) AND (DOCUMENTUM ) AND (RISK ASSESSMENT ) AND (TRACEABILITY ) AND (PART 11 OR CFR 21 ) AND(VALIDATION PLANS )

        Keywords: Alpha Consulting Corp., New Brunswick , Computer Systems Validation Specialist, IT / Software / Systems , New Brunswick, New Jersey

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