Job TitleExperience in validating laboratory and labeling systems5+ years’ experience with System Development Lifecyle 10+ years’ experience in Computer System Validation (Based on the role selected)Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.Experience in writing and executing documentation for all aspects of the validation deliverables (etc.
Requirements, Compliance Plans, test protocols, Test Summary reports and Compliance ReportsExperience in reviewing system test and user acceptance test scripts, defect management, Traceability matrix and Design Specs.
Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.Preferred tools knowledge and experience: JIRA, qTest, ServiceNow, XRAY and Change Record reviewTechnology Quality representative and provide quality guidance from a CSV perspective based on CSV Framework and SDLC processStrong verbal and written communication skills.Ability to work as a team player, lead a team or accomplish tasks without supervision.Ability to work with remote teams and support several changes/projects simultaneously.