QA　ワクチン・再生医療等製品担当

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Job details

Company overview

Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.

Responsibilities

• 品質課題対応/変更管理/逸脱/品質情報/品質契約/GMP 監査/製造委託先の Data Integrity 維持・向上等
• 製造委託先等管理業務の推進と業務改善
• 当局査察の準備推進・製造所の支援
• 製造委託先等の GMP 向上支援? 当局提出資料（IND/IMPD、CTD、承認申請書、試験報告書等）の信頼性の確保

Requirements

必須条件：

• ワクチン、バイオ医薬品、または新規モダリティ品目の国内品質保証(GQP)の経験
• 医薬品の CMC 研究、製造・品質に関する実務経験又は知識

歓迎条件：

• グローバル品目の品質保証経験
• 国内外当局査察対応経験、新製品の国内外申請業務の経験、製造所の GMP監査経験
• 海外と折衝ができる英語力（目安として TOEIC750 点以上）

Salary

6 - 10 million yen

Location

Tokyo