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GxP Validation Analyst

GxP Validation Analyst

Katalyst Healthcares and Life SciencesHighland Heights, KY, United States
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Job Description :

  • Documenting and validating instrument software per EMA guidelines.
  • Migrating instrument software management into PPD IT SOP frameworks.
  • Capturing requirements, configurations, and compliance documentation to ensure end-to-end traceability and regulatory compliance.

Responsibilities :

  • Gather and document requirements (URS, software configuration).
  • Develop and execute validation test cases (IQ, OQ, PQ as applicable).
  • Prepare requirements specifications, infrastructure diagrams, and data flow diagrams.
  • Conduct risk assessments and ensure traceability (requirements → risks → tests → results).
  • Support SOP migration and alignment with PPD IT practices.
  • Communicate effectively with lab teams, IT, QA, and external vendors.

    • Requirements :

  • Strong technical writing and documentation skills.
  • Proven experience in software validation of lab instruments / other GxP systems.
  • Good understanding of EMA guidelines, Annex 11, and GAMP 4.
  • Ability to design and interpret infrastructure and data flow diagrams.
  • Detail-oriented with strong stakeholder engagement and communication skills.
  • 6-9 years of relevant validation experience in pharma, biotech, or CRO environments.
  • Familiarity with CSA (Computer Software Assurance) principles preferred.
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    Gxp Validation Analyst • Highland Heights, KY, United States