エージェント取り扱い求人

プログラム医療機器(SaMD)開発に関わる品質管理業務★東京

募集中
  • 勤務地
    東京都
  • 職種
    品質管理担当
  • 業種
    CRO

募集要項

業務内容 【業務体制】
  ・工程管理、リスク分析を行い最善の品質管理手順を検討するところから、依頼者への書類の移管まで、幅広く業務を行っています。
  ・標準業務手順書やマニュアルに従って業務は行われますが、これらについても常に改善することを念頭に業務を行っています。
  ・業務実施部門とチームを組んで共同作業をします。

【キャリアパス】
  ・未経験者:導入研修でGCP,SOPを学んでいただき、サポート業務からスタートします。 
  ・経験者:臨床試験の品質管理だけではなく、画像解析業務や臨床研究に関連する品質管理など、幅広くキャリアを広げることができます。
  医療機器の申請から販売まで、書類を通じて全体像を見ることができ、品質管理の経験を活かして、ISOの内部監査や品質保証、ライティング、コンサルティング業務のスキルを身につけることができます。

【やりがい】
  ・定型業務をこなすだけではなく、意見交換しながらより業務しやすい環境を作り上げていくことができます。
  ・モニタリングQCだけでなく、画像解析や臨床研究に関連するQC、また医薬品だけでなく医療機器まで幅広い業務に関わることができます。
  ・開発業務受託機関(CRO)としての活動と、医療機器製造販売業者(医療機器メーカー)としての活動を行っており、
   プログラム医療機器の業界では、開発・支援の実績がNo.1です。そこにはノウハウ・暗黙知があります。
   それを活かして医療に貢献していくことがミッションです。
雇用形態 正社員
応募資格 【必須要件】
・理系の高専もしくは大卒以上の学歴
・社会人経験3年以上
・文書作成や資料作成が速やかにできるPCスキルを持った方
英語力 問わない
年収 380万 〜 450万円
給与詳細 年収レンジ:理論年収 380~450万円 
      【月額基本給】23万円~28万円
      【賞与】月額基本給×2ヵ月±α(を年2回)
      【昇給】年1回
      【諸手当】通勤交通費(月額上限5万円)、役付手当 等
勤務地 東京都
備考

企業情報

匿名

関連する求人

エージェント取り扱い求人
Manager or Specialist, Quality Assurance, Hikari Plant / 光工場 品質保証担当(課長代理または一般社員)

【職務内容】 光工場において、医薬品の品質管理及び品質保証業務における以下業務を担うリードもしくは担当者です。 ・ショップフロアQA(現場作業を直接監視・監督) ・バッチレコードを含む書類の照査 ・逸脱調査 ・出荷判定  ・バリデーション ・変更管理 ・試験記録のレビュー など 業務範囲は、光工場の生産部門及び試験部門であり、対象製品は原薬/固形製剤、麻薬製剤などがありますので、適性と経験を考慮します。 【キャリアの展望】 この業務を経験されると、国内外の医薬品に関する品質保証業務全般の知識スキルを習得する事が出来ます。また、光製薬品質保証室には、原薬、固形製剤、無菌製剤、ワクチンを担当するグループもあり、品質保証室内のローテーションにより幅広い剤型に対する品質保証エキスパートになれる機会が得られます。

  • 500万〜1300万
  • 山口県
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募集中

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募集中

エージェント取り扱い求人
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  • 山口県
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募集中