GxP Validation AnalystKatalyst Healthcares and Life Sciences • Highland Heights, KY, United States
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GxP Validation Analyst
Katalyst Healthcares and Life Sciences • Highland Heights, KY, United States
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job_description.job_card.job_descriptionGather 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. 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.
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 :
Requirements :
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Gxp Validation Analyst • Highland Heights, KY, United States
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