What are the responsibilities and job description for the QA with CSV Oversight Consultant position at Katalyst CRO?
Job Description
Provide Quality Assurance (QA) oversight for Computer Systems Validation (CSV) activities supporting the LabVantage 8.7 enhancement project and other digital initiatives. This role is focused on reviewing and approving validation documentation, not authoring it, though prior experience in writing such documentation enables effective challenge and feedback when necessary.
Roles & Responsibilities
Provide Quality Assurance (QA) oversight for Computer Systems Validation (CSV) activities supporting the LabVantage 8.7 enhancement project and other digital initiatives. This role is focused on reviewing and approving validation documentation, not authoring it, though prior experience in writing such documentation enables effective challenge and feedback when necessary.
Roles & Responsibilities
- Review and approve Installation Qualification (IQ), Performance Qualification (PQ), and validation summary reports from a quality perspective.
- Provide Computer Systems Validation (CSV) QA services supporting the LabVantage 8.7 enhancement and/or other digital projects, as needed.
- Provide CSV QA oversight (review and approvals) for digital projects.
- Review validation test protocols, test scripts and validation lifecycle documentation, as required.
- Ensure standard best practices (e.g. GxP, 21 CFR Part 11, Annex 11, ICH, GAMP5) are followed with respect to computerized systems and data integrity.
- Ensure internal policies and SOPs are adhered to for CSV lifecycle documentation.
- Candidate has prior experience authoring validation documents and can provide effective quality oversight and challenge when appropriate.
- Focus is on quality oversight rather than document authorship.
- If don't have LabVantage 8.7 some sort of LIMs or QC heavy.
