業務内容 製薬業界における品質管理のエキスパートとして、規制要件への適合と監査対応を主導するポジションです。医薬品製造プロセスの効率化と品質向上を実現し、GMP基準に準拠した品質管理システムの維持に貢献します。 このポジションでは、以下の役割を担っていただきます： 内部および外部監査のサポートと対応策の立案・実施 品質管理システムの評価と改善提案の実施 規制要件に基づいた標準作業手順書(SOP)の作成と実装 GMPリスク評価の実施と品質管理プロセスの最適化 クライアントの品質管理部門と連携した問題解決と継続的改善活動の推進 ミッション 製薬業界における品質管理のエキスパートとして、当社のAutomation Quality Management Consultantは、クライアントの医薬品製造プロセスにおける品質保証と規制遵守の最前線に立ちます。このポジションでは、高度な専門知識と革新的アプローチを駆使して、GMP基準に準拠した品質管理システムの構築・維持・改善を主導します。内部・外部監査への対応から品質管理システムの評価、SOPの作成・実装、GMPリスク評価の実施まで、包括的な品質管理フレームワークを確立することで、クライアントの製品品質と患者安全を確保します。また、継続的改善の文化を促進し、品質管理プロセスの最適化を通じて、クライアントの競争力強化と規制環境における信頼性向上に貢献します。当社のエンジニアリングアカデミーを通じた継続的な学習機会を活用しながら、製薬業界特有の品質管理課題に対する革新的ソリューションを開発・提供することで、クライアントとともに医薬品製造の未来を形作ります。コンプライアンス、品質、規制（CQR）の専門家として、製品の安全性、性能、規制基準への適合を製品ライフサイクル全体にわたって保証する重要な役割を担います。 ロケーション 東京、リモートワーク （現時点で週の半分程度リモートワーク） 国内クライアント拠点への出張の可能性あり 職務詳細 戦略と組織開発 内部および外部監査のサポート 標準の実装 必要に応じて、地域/サイトのSOPとテンプレートの作成 保守とキャリブレーション 保守/キャリブレーションのリスク評価の実施 保守/キャリブレーション/プロジェクトの許可取得 品質への影響評価と保守後の解放 保守文書のアーカイブ 変更要求の実行 逸脱の調査（根本原因分析） プロジェクトエンジニアリングとコントロール プロジェクトリスク評価の実施 プロジェクトにおける機器仕様とシステム要件の準備（例：ユーザー要求仕様書） プロジェクトにおける機能仕様書の準備 方法声明書に従ったプロジェクトの作業指示の実行 再適格性評価 GMPリスク評価の実施経験（センサーSRAを含む） DQ、IQ、OQプロトコルの作成経験 DQ、IQ、OQの実行経験
Job Description: Business Overview The Technology Management Division (TMD) provides Corporate IT, and Cyber Security & Privacy Governance to Rakuten Group companies and essential business management for technology organizations, thereby enabling innovation and strengthening the technology foundation. Within
Job Description: Business Overview The Technology Management Division (TMD) provides Corporate IT, and Cyber Security & Privacy Governance to Rakuten Group companies and essential business management for technology organizations, thereby enabling innovation and strengthening the technology foundation. Within
Job Description: Business Overview Rakuten Group provides more than 70 services in a wide range of fields, including e-commerce, travel, digital content, and other Internet services in Japan and overseas, as well as financial services such
Job Description: Business Overview Ad & Media Company leads the Advertising Business, one of the core growth pillars of the Rakuten Group. By maximizing the power of the Rakuten Ecosystem and leveraging data and technology, we
Job Description: Business Overview The Technology Management Division (TMD) provides Corporate IT, and Cyber Security & Privacy Governance to Rakuten Group companies and essential business management for technology organizations, thereby enabling innovation and strengthening the technology foundation. Within
Job Description: Business Overview The Technology Management Division (TMD) provides Corporate IT, and Cyber Security & Privacy Governance to Rakuten Group companies and essential business management for technology organizations, thereby enabling innovation and strengthening the technology foundation. Within
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Who We Are Applied Materials is a global leader in materials engineering solutions used to produce virtually every new chip and advanced display in the world. We design, build and service cutting-edge equipment that helps our
Location:Hitachi, Ibaraki, Japan Job ID: R0125577 Date Posted:2026-05-08 Company Name:HITACHI ENERGY JAPAN, LTD. Profession (Job Category):Quality Management Job Schedule: Full time Remote:No Job Description: The opportunity Hitachi Energy Service is a trusted lifecycle partner, providing customers with secure,
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