Gotenba, Shizuoka L'Oréal

ミッション(期待する成果)薬機法の化粧品/医薬部外品の製造業者の責任技術者の任務を遂行するとともに、必要な薬機法上の届出をもれなく行う。

(御殿場工場に関連する法令の統括)仕事内容1化粧品および医薬部外品の製造における薬機法に基づく責任技術者業務全般

  • 製造業許可の維持管理
  • 完成品の出荷判定
  • 薬機法順守評価/修正・是正
  • 静岡県薬事規制対応(立ち入り調査/収去) 2海外での製品登録に必要なサポート/証明書(FSC/GMP/輸出証明)の提供 3工場に関連する法令の統括リーダー

薬機法・その他関連法令の遵守評価及び修正・是正 4原料の化学物質管理、原料/完成品の輸出入に関連する情報/書類等の提供 5薬事室のチームマネージメント応募資格必須要件化粧品/医薬部外品の責任技術者資格要件である下記条件のいずれかを満たしていること

条件1: 薬剤師免許をお持ちの方

条件2: 化粧品・医薬部外品の責任技術者業務のご経験のある方

条件3: 高校-大学で薬学又は化学に関する専門課程を修了された方

条件4: 高校-大学で、薬学又は化学に関する科目を修得した後、医薬品/化粧品の製造/品質に関する業務に3年以上従事した者(能力・経験)薬機法の基礎的な知識 化学の知識 メールのやりとりができるレベルの英語コミュニケーションスキル 歓迎要件FD(薬機法のすべての届出書類を行うための医薬品医療機器等法用医薬品等電子申請ソフト)申請経験 化粧品GMPに関する知識・経験 化粧品の品質管理、工程管理、安全管理に関する知識・経験 薬機法以外の法令の知識(労働安全衛生法、消防法等)望ましい人物像1協調性

2妥協せずに物事に取り組む(パーソナリティ)3問題解決能力



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