職務概要 Position Summary: ( オペレーションサポート業務 /Operation Supports) Ø オペレーション分野(倉庫,製造サポート,生産効率)でチームメンバーの業務のとりまとめを行い,富士工場での製造関連業務がスムーズかつ効率的に行われるよう部門•チームをリードする。 Ø 製造プロセスにおけるデジタルトランスフォーメーションを加速させるため,既存プロセスにおける課題発見,解決 に向けたソリューションの提案,実行を推進する。また海外のデジタル担当者と連携し,各 J&J サイトで導入しているデジタルソリューションの導入を検討•推進する。 Ø 今後の製造部の方向性•戦略の立案•実行。 Ø 安全,品質,信頼性,コストについての価値を提供するため,積極的に社内のプロジェクトに参画し,安全•品質文化の構築含め,•担当分野のリスク管理•継続的な改善の実施のリードを行う。 Ø JJRC, 外部 GMP/CGTP 査察等からの指摘事項に関する継続的な改善をチームの一員として積極的に行う。 Ø 部門の目標に対する KPI 達成に向け,責任範囲の KPI に責任を持ち, KPI 達成に向けたアクションプランや改善策を構築•実践する。 Ø 積極的に能力開発を実施し,自身の能力向上だけにとどまらず,部門全体の能力開発向上に寄与できるように取り組む。 Ø チームメンバーと定期的に1 on1 を行い,本人だけでなく,チームメンバーのパフォーマンス向上や,業務効率改善,課題解決にむけたコーチングを実施する。
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( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
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