What are the responsibilities and job description for the GxP LabVantage LIMS Consultant position at LS Solutions?
We are seeking an experienced GxP LabVantage LIMS Consultant to lead the full implementation, documentation, and validation of a LabVantage LIMS project in a GxP regulated environment. The ideal candidate will have hands-on experience in system implementation/configuration, writing design specifications, and validation processes. Experience with ValGenesis for validation management is a plus.
Labvantage LIMS Consultant Responsibilities:
- Lead the end-to-end implementation of LabVantage LIMS in a GxP-regulated laboratory environment
- Perform configuration of the system to align requirements to functionality
- 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
- Collaborate with cross-functional teams including IT, Quality Assurance, and Lab personnel
- Manage system configuration, testing, and troubleshooting
- Prepare comprehensive project documentation including URS, FRS, Configuration Specs, and Test Scripts
- Utilize ValGenesis for validation lifecycle management, ensuring an efficient and compliant validation process
- Provide training and support to end users
Requirements:
- 5 years of experience implementing/configuring and validating LabVantage LIMS in a GxP environment
- Strong expertise in design specification authoring and system documentation
- 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
- Strong problem-solving skills and the ability to troubleshoot technical issues
- Excellent communication and collaboration skills
