GxP Validation Analyst
GxP Validation Analyst
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1 Vacancy
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.
- 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.
- 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.
Employment Type
Full-time
