GMDP Auditor, Quality Audit Excellence

Description 【募集の背景 / Purpose & Scope】 Conducts cGMP, cGDP or device audits of suppliers and internal entities and systems in support of the supplier evaluation and risk assessment program. 【職務の内容 / Essential Job Responsibilities】 （雇入れ直後） 1.Leads cGMDP audits of suppliers in support of the supplier evaluation and risk assessment program to identify / evaluates all risks. Develops and distributes formal reports in a collaborative manner. Ensures related databases are updated in a timely manner and generates status reports as required. 2.Leads internal cGMDP and medical device audits. Identifies and evaluates relevant potential internal quality and compliance issues, signals and trends. Prepares and distributes formal reports in a timely manner. Updates related databases in a timely manner and generates status reports as required. 3.Participates as the QA representative on Astellas projects and working teams as assigned. 4.Supports continuous improvement, innovation, compliance and...