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Sr Spec, Microbiological Lab

Req # 1900053F Location Miyazaki, Miyazaki, Japan Job Category Quality Control Date posted 12/27/2019

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Position ポジション


1900053F Sr Spec, Microbiological Lab

Organization 所 属

品質管理試験 宮崎

Role Overview 職務概要


Key Responsibilities    主な職務内容

  • バクスターの品質方針および関連する各種法令・規則に従い、以下に示す微生物学試験または化学試験を実施する。
  • 製造支援システムに関する試験
  • 環境モニタリング試験
  • 原料材の受入試験
  • 工程内試験
  • 中間製品および最終製品の試験
  • GMP関連文書などを作成・メンテナンスする。
  • 試験機器・装置を定期的に校正する。
  • 試験室主導のバリデーションを実施する。また、他部門主導のバリデーションへ参画する。

Qualifications  求められる経験・スキル・知識

  • 製薬業界(または化粧品、化学、食品業界)における最低3年程度の品質管理業務経験(分析操作経験)または医薬品・医療機器業界における最低3年程度の品質保証業務経験
  • 医療または医薬業界に関する基礎知識
  • 薬機法、GMP、日本薬局方などの公定書の基本的な理解
  • 社内外の関係者と円滑な関係を築くコュニケーションスキル
  • 大学卒業レベル程度の英語力(電子メール、SOPなどを読み書きできる英語力)
  • 薬剤師資格(必須)

Master's Degree (±18 years) - Pharmacology, Registered Pharmacist (RPh) - Other

Reasonable Accommodations

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