職務内容：
医薬品、医療機器(有形、および医療機器プログラム)、および再生医療製品等の品質保証業務（これまでの業務経験等に基づき担当業務を考慮）

・製造委託先、試験委託先ならびに原材料業者の監査業務全般
・国内外の製造業者、販売提携先、輸出品ライセンシー、輸送業者等との品質契約内容の交渉、契約書・関連文書の作成、契約締結
・品質調査（苦情）対応
・製品やその品質保証に関するプロジェクト推進やロシュ社とのコミュニケ―ション
・品質システムの維持・向上
・グローバルPQS要件の運用推進業務
・海外販社におけるGMP/GDP業務の管理監督
・SaMDの開発・製造販売に関わるQMS業務

Description of Work:
Corporate Quality Assurance operations in compliance with GQP, QMS, GMP/GDP, GCTP requirements.

・Auditing manufacturing and testing sites, warehouse, distributors and suppliers
・Preparation and conclusion of quality agreement and liaison with manufacturing and testing sites, sales partners, product licensees, warehouses, distributors and suppliers
・Complaint handling and support of an effective complaints management process
・Project management and/or commumication with Roche as to product quality issues and quality assurance
・Maintainance and improvement of quality systems
・Support of the implementation and maintenance of Pharmaceutical Quality System in line with global standards
・Management and support of GMP/GDP operations in overseas affiliates
・QMS operations related to SaMD in development and commercial phase

職種の魅力：
これまでの低分子・バイオ医薬品に加え、遺伝子診断、中分子、再生医療製品等新たな製品群の開発が急ピッチで進んでいます。従来の規制ではカバーしきれない領域での品質保証には困難さを伴いますが、当局や国内外パートナー企業との連携により、様々な課題に取り組み解決していくことのできるチャレンジングな職種です。

Position Features:
In addition to conventional chemical and biopharmaceutical products, new products and services such as genome profiling, medium-molecular-weight products, and regenerative medicine products have been developed on a fast track. Although quality assurance in areas that cannot be covered by conventional regulations is challenging, it is rewarding to solve various issues by cooperating with authorities and domestic and overseas partner companies including Roche.