· Ensure that the Quality Principles are being followed during qualification of materials for Production, Manufacturing departments.
· Perform risk assessment to ensure that all the possible risks factors like patient safety, product quality and data integrity are evaluated to assess the overall system/Ensure that the product meet the specifications and intended use is being met
· Creating new templates updating and revising Supplier Quality Agreements and quality requirement.
· Prepare all documentation in accordance with FDA regulations including 21 CFR Part 11.
· Ensure that all the quality related documents such as qualification Plan, User Requirement Specifications, User Stories, Master Test Plan, System Test Protocol, User Acceptance Test Protocol, Test Summary Reports, Validation Summary Reports are created and maintained.
This position requires a minimum of Bachelor’s degree in Computer Science or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in Computer Science or a closely related field.
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