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品質管理 担当// QC Staff

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医薬品受託開発製造企業にて品質管理担当の募集がございます。主に医薬品工場における品質管理業務や市販後医薬品の安定性試験などをご担当いただきます。業務状況に応じて最大で週2日の在宅勤務が可能なポジションです。勤務地は埼玉県です。

職務内容:

  • 医薬品製造に関わる原材料および製品の品質試験スケジュール作成、試験実施および判定業務
  • 医薬品のプロセスバリデーション、洗浄バリデーション、分析法バリデーションに係る品質試験の計画書作成、試験実施および報告書作成
  • 医薬品製造エリアの環境モニタリングおよび製造用水管理の計画書作成、試験実施および報告書作成
  • 市販後医薬品の安定性試験(安定性モニタリング、加速試験、長期保存試験)の計画書作成、試験実施および報告書作成
  • 品質管理システムの維持管理

応募要件:

  • 医薬品工場、または研究所、またはそれに類する施設における分析業務経験
  • PCスキル(Word・Excel・PowerPoint・Outlook)
  • 読み書きレベルの英語力
  • 医薬品GMPに関する知識尚可
  • ビジネスレベルの英語力尚可

会社概要:

グローバルに事業を展開するCDMO(医薬品受託開発製造企業)。急成長しており、高品質な医薬品の安定供給における更なる発展が期待できる企業です。

求人番号: N3Q0J2

Contract Type: Perm

Specialism: Healthcare

Focus: Quality Assurance

Industry: Pharmaceuticals

Salary: ¥5,000,000 - ¥9,000,000 per annum

Workplace Type: Hybrid

Experience Level: Associate

Language: Japanese - Professional working

Second Language: English - Basic

Location: Tokyo

Job Reference: N3Q0J2-A262A7CF

Date posted: 22 July 2025

Consultant: Ryosuke Kikuchi