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CSV QA Oversight Consultant
A company is looking for a CSV/QA Oversight Consultant. Key Responsibilities Review and approve Installation Qualification (IQ), Performance Qualification (PQ), and validation summary reports Provide Computer Systems Validation (CSV) QA services for the LabVantage 8.7 enhancement and other digital projects Ensure adherence to standard best practices and internal policies for CSV lifecycle documentation Required Qualifications Prior experience in authoring validation documentation Experience with LabVantage 8.7 or similar Laboratory Information Management Systems (LIMS) Knowledge of GxP, 21 CFR Part 11, Annex 11, ICH, and GAMP5 standards Understanding of computerized systems and data integrity Ability to provide effective quality oversight and challenge documentation when necessary
A company is looking for a CSV/QA Oversight Consultant.
Key Responsibilities
Review and approve Installation Qualification (IQ), Performance Qualification (PQ), and validation summary reports
Provide Computer Systems Validation (CSV) QA services for the LabVantage 8.7 enhancement and other digital projects
Ensure adherence to standard best practices and internal policies for CSV lifecycle documentation
Required Qualifications
Prior experience in authoring validation documentation
Experience with LabVantage 8.7 or similar Laboratory Information Management Systems (LIMS)
Knowledge of GxP, 21 CFR Part 11, Annex 11, ICH, and GAMP5 standards
Understanding of computerized systems and data integrity
Ability to provide effective quality oversight and challenge documentation when necessary