Job number: Job-00211292 Posted: 2024-04-22

品質保証 QA

Global Company
6 - 12 million yen Tokyo Pharmaceutical Quality Assurance / Quality Control

Job details

Company overview
We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
Responsibilities
  • 医療機器、再生医療製品等を含む新たなモダリティへの業務展開
    • 新たな技術の導入、技術の進化
    • サプライチェーンの多様化
  • グローバル製品(開発品・市販品)の増加
    • 製造委託先、試験委託先ならびに原材料供給業者の増加
    • そのため、GQP/GMP/QMS/GCTP/GDP等に関する品質保証業務に精通した要員の補充が必要となった。
  • IND/IMPD、NDA/BLA作成及び推進、国内申請資料作成及び推進、その他CMC薬事にかかわる業務 
Requirements
  • GQP/GMP/QMS/GCTP/GDP等に関する品質保証業務経験(国内・海外問わず)のある方。
  • 医薬品/医療機器/再生医療製品等のCMC(Chemistry,Manufacturing and Control)に関する業務経験又は他業種における品質保証業務経験があり、GQP/GMP/QMS/GCTP/GDP等に関する品質保証業務に興味のある方。
Salary
6 - 12 million yen
Location
Tokyo
Patrick Chang
BRS Consultant
Patrick Chang
Pharma
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