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Validation - Validation Specialist

  • Location: New Brunswick
  • Job Type:Contract

Posted 18 days ago

  • Expiry Date: 09 December 2021

​​Job Description:

  • 6+ years experience
    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.
    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

About ASK:ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.