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Analyst, IT Validation

Company: Katalyst Healthcares & Life Sciences
Location: South Plainfield
Posted on: May 28, 2023

Job Description:

Responsibilities :

  • Validation Services and Technical Writing
  • Creation, review, approval, and processing of Computer System Lifecycle deliverables including:
  • User Requirements, Specifications, Test Plans, and IQ, OQ or PQ Test Scripts
  • Implementation of the most appropriate validation methodology for the Business effort.
  • Fostering of effective relationships with IT customers to better understand processes and requirements and attaining the most beneficial computer system solutions that meet all relevant regulatory standards.
  • Active engagement with ISQA to ensure compliance on IT projects and enhancement efforts.


    • BS/Equivalent Training/Certification and minimum of 2 years of relevant experience in computer systems validation, systems development life cycle methodologies and change management.

      Necessary Knowledge, Skills, and Abilities

      • Expertise in computer system validation, Systems Development Life Cycle (SDLC) methodologies.
      • Knowledge of computer system regulations, standards, and best practices
      • Strong versatility of written and verbal communication skills, including documentation of requirements, technical solutions, and primary validation documentation
      • Demonstrate strong technical writing skills and ability to teach others in the application of technical writing principles.
      • Technical knowledge of the following computer systems and software (at a minimum):
      • Microsoft software packages such as Outlook, Word, Excel, PowerPoint, Explorer, and MS Project
      • Veeva Vault
      • Document Management Systems /QA Systems.
      • Working knowledge of project management principles, and ability and experience to operate under tight timelines, within budget and to specified quality and compliance goals.
      • Solid relationship and conflict management skills and ability to navigate complex, fast[1]moving, and constrained business environments in a self-directed manner.
      • Strong work ethic, learning and change agility, operates comfortably and effectively in an ambiguous and fast-paced environment.

Keywords: Katalyst Healthcares & Life Sciences, New York , Analyst, IT Validation, Professions , South Plainfield, New York

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