Job Summary
A company is looking for a LabVantage LIMS Validation Specialist to lead the documentation and validation of LabVantage LIMS projects in a GxP regulated environment.
Key Responsibilities
- Lead the end-to-end documentation and validation processes of LabVantage LIMS in a GxP-regulated laboratory environment
- Author and maintain Design Specifications, ensuring alignment with regulatory and business requirements
- Develop and execute validation protocols (IQ/OQ/PQ) and ensure compliance with GMP, GLP, and GCP standards
Required Qualifications
- 5+ years of experience validating LabVantage LIMS in a GxP environment
- Strong expertise in CSV/Lab Systems Qualification document/deliverable authoring
- Experience with ValGenesis or similar validation lifecycle management tools
- Solid understanding of GxP, 21 CFR Part 11, and Data Integrity compliance requirements
- Ability to work independently and lead implementation projects with minimal oversight
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