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Qualification & Validation Specialist

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Katalyst HealthCares & Life Sciences
πŸ“ Redwood City, United States
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Location Redwood City
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Posted June 17, 2026
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Commute Local Area
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Job Description


Job Summary:
  • We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments.

  • This role is critical in ensuring our cloud infrastructure meets regulatory compliance standards (, GxP, HIPAA, ISO ) through robust validation and documentation practices.
  • Roles & Responsibilities :
  • Develop and maintainIQ/OQ/PQ documentation for AWS infrastructure components.

  • Collaborate with DevOps and Cloud Engineering teams to understand architecture and deployment models.

  • Ensure infrastructure is validated according to GAMP and Computer System Validation (CSV) principles.

  • Create and manage traceability matrices, risk assessments, and validation plans.

  • Support internal and external audits by providing documentation and evidence of compliance.

  • Maintain vers...
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    πŸ“ Location Details

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    City
    Redwood City
    πŸ—ΊοΈ
    Country
    United States
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    Commute
    Local Area

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