Quality Assurance Consultant

A company is looking for a Quality Assurance Consultant to provide oversight for Computer Systems Validation activities. Key Responsibilities Review and approve Installation Qualification (IQ), Performance Qualification (PQ), and validation summary reports Provide Computer Systems Validation (CSV) QA services for digital projects, including the LabVantage 8.7 enhancement Ensure compliance with best practices and internal policies for CSV lifecycle documentation Required Qualifications Prior experience in authoring validation documents Knowledge of GxP, 21 CFR Part 11, Annex 11, ICH, and GAMP5 standards Experience with LabVantage 8.7 or similar Laboratory Information Management Systems (LIMS) Ability to provide effective quality oversight and challenge documentation as necessary Experience in quality assurance within regulated industries

Apr 14, 2025 - 23:13

A company is looking for a Quality Assurance Consultant to provide oversight for Computer Systems Validation activities. Key Responsibilities Review and approve Installation Qualification (IQ), Performance Qualification (PQ), and validation summary reports Provide Computer Systems Validation (CSV) QA services for digital projects, including the LabVantage 8.7 enhancement Ensure compliance with best practices and internal policies for CSV lifecycle documentation Required Qualifications Prior experience in authoring validation documents Knowledge of GxP, 21 CFR Part 11, Annex 11, ICH, and GAMP5 standards Experience with LabVantage 8.7 or similar Laboratory Information Management Systems (LIMS) Ability to provide effective quality oversight and challenge documentation as necessary Experience in quality assurance within regulated industries