GXP Validation Analyst
Katalyst Healthcares and Life SciencesHighland Heights, KY, United States6 hours ago
Job type
- Full-time
Job descriptionGather and document requirements (URS, software configuration). Write and execute validation test cases (IQ, OQ, PQ as applicable). Support to prepare requirements specifications, infrastructure & data flow diagrams. Perform risk assessments and ensure traceability of requirements → risks → tests → results. Support SOP migration and alignment with PPD IT practices. Communicate effectively with lab, IT, QA, and vendor teams. Strong technical writing & documentation skills. Experience in software validation (lab instruments / GxP systems). Knowledge of EMA guidelines, Annex 11, GAMP 4. Ability to create infrastructure / data flow diagrams. Detail-oriented with strong communication and stakeholder engagement skills. 6-9 years relevant validation experience (pharma / biotech / CRO ). Familiarity with CSA Principles.
Job Description :
- Global Instrument Software Validation Project covering 200 unique instruments. Scope includes.
- Documenting and validating software installed on lab instrumentation per EMA guidelines.
- Migrating and adherence of instrument software management to PPD IT SOPs.
- Capturing requirements, configurations, and compliance documentation.
Responsibilities :
Requirements :
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Gxp Validation Analyst • Highland Heights, KY, United States
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