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品質管理・分析技術スペシャリスト// QC Specialist

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受託製薬製造専門企業にて品質管理および分析技術スペシャリストの募集です。プロジェクト主担当として、窓口業務や課題解決等を行っていただきます。工程内検査の部署においては、一部交替勤務が発生します。勤務地は埼玉県です。

職務内容:

  • 固形剤・注射剤の市場への出荷試験および安定性試験
  • バルク製剤の入荷試験を含む理化学試験
  • 賦形剤および原薬の入荷時の理化学試験
  • 包装資材の入荷検査および最終製品の外観・表示検査
  • バイオ医薬品(抗体医薬・核酸医薬・タンパク質製剤・ペプチド製剤・ワクチン製剤)の市場への出荷試験・安定性試験、またバルク製剤の入荷試験を含むバイオ試験
  • 無菌製剤の無菌試験および医薬品および医薬品原料の微生物限度試験
  • エンドトキシン試験
  • 製造エリアの環境モニタリング
  • 各製造工程における物性を中心としたQCによる品質評価

応募要件:

  • 医薬品もしくは化粧品・食品等の品質管理経験3年以上
  • 分析法開発・分析法の技術移管業務・USP/EPに対応した試験経験尚可

会社概要:

受託製薬製造専門企業。豊富な経験、蓄積されたノウハウを活かし、製剤開発から医薬品製造までクライアントの要望に合わせて支援しています。

求人番号: JBNNN4

Contract Type: FULL_TIME

Specialism: Healthcare

Focus: Quality Assurance

Industry: Pharmaceuticals

Salary: ¥4,500,000 - ¥7,000,000 per annum

Workplace Type: On-site

Experience Level: Associate

Language: Japanese - Professional working

Location: Saitama

Job Reference: JBNNN4-37097B82

Date posted: 14 June 2025

Consultant: Ryosuke Kikuchi