Computer System Validation

Company: Alpha Consulting
Location: Princeton
Posted on: March 17, 2023

Job Description:

COMPUTER SYSTEM VALIDATION PRINCETON, NJ ***Work onsite 50% of the time, so local candidates only please*** Required Skills:

• Bachelor's Degree.
  • 3 years of CSV lead experience.
  • 3 years of HP ALM.
  • 3 years of CSV Documentation author and review, approve.
  • 1-2 years of experience in Change Control.
    • 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.
    • 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.
    • Experience/understanding of Data Integrity concepts.
    • Understanding of GAMP categories and validation approaches. 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 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: ALPHA'S REQUIREMENT #23-00460 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Keywords: Alpha Consulting, Trenton , Computer System Validation, Other , Princeton, New Jersey