CSV/Validation Specialist

New Brunswick, New Jersey
Industry: Biotech / Pharma
Job Number: JN -062021-64956

Job 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

Required Qualifications:

3+ years of Project Management

3+ years of GXP System Validation/21CFR Part 11

3+ years of HP ALM

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