For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai.Job DescriptionCatalyx is seeking a Quality Assurance Computer System Validation (CSV) to play a pivotal part in ensuring the compliance and efficiency of computerized systems within the new facility, contributing to the successful implementation of our operations.Primary ResponsibilitiesResponsible for providing quality assurance support and oversight for System Development Life Cycle (SDLC) deliverables of primarily Laboratory Instrument Systems and secondary for Application Systems support GxP operationsCollaborate with cross-functional team to define risk-based approaches for computer system validation activities and testing.Lead validation teams to a better understanding of validation best practices and applying quality principles.Reviews various GxP deliverables for conformance with SDLC baseline criteria and other internal and external regulations.Identifies and resolves issues interfering with execution of deliverables.Enforces Good Documentation Practices and ensures that SDLC deliverables are properly cataloged and available for internal and external regulatory inspection.Provide additional support with SDLC deliverables for Enterprise Application support, as applicable.Perform Supplier Assessments to ensure vendor compliance to regulations and standards before introducing instruments or applications into the lab environment.Attend meetings as quality representative and capture meeting minutes, escalating items as appropriate.Oversee team’s progress and accomplishments on instrument validation activities ensuring project remains on target for key milestones.Requirements...
