GXP Validation Analyst
Katalyst HealthCares & Life Sciences
Global Instrument Software Validation Project
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:
- Gather 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.
Requirements:
- 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.
Vacancy posted 4 days ago
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