better Software Quality Engineer

OBJECTIVES: The Software Quality Engineer (EDQA- Electronic Data Quality Assurance) supports regulated software quality assurance compliance efforts both within Takeda and at Takeda contracted manufacturing vendors and research sites, to ensure the following: 1. Effective implementation of computer validation and compliance with global electronic records and electronic signature regulations (US: 21 CFR Part 11, EU: Annex 11, Japan: Notice 0401022) throughout the corporation, including regulated information systems, Takeda internal policies and procedures. 2. Effective development and implem...

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