【富山】Specialist, Toyama QA, Biopharma QA

Description 【募集の背景 / Purpose & Scope】 This position will play a central role in carrying out all of the assigned quality assurance duties. Specifically, he/she will perform the tasks listed below. However, as quality assurance duties are broad and cover the entire quality management system, there are a variety of tasks involved. ・Change management ・Deviation management ・CAPA management ・Validation management ・Responding to related inspections by domestic and international authorities ・Collaboration within the company and with partners 担当する品質保証業務全般にわたって、実務遂行の中心的な役割を担って頂きます。具体的には、以下に示すような業務遂行となります。ただし、品質保証業務は品質マネジメントシステム全体の多岐にわたりますので、様々な業務がございます。・変更管理業務・逸脱管理業務・CAPA管理業務・関連する国内外当局査察対応業務・社内及び提携先との連携【職務の内容 / Essential Job Responsibilities】 （雇入れ直後） ・ To have knowledge and experience in quality assurance under pharmaceutical GMP or investigational drug GMP (including overseas regulations such as CGMP and PIC/S GMP) and can promote quality assurance work by communicating on a daily basis...