- グローバル製薬業界のコンプライアンスにおけるQAリーダー
- 国際的なステークホルダーと協働する機会
企業情報
日本で強い存在感を持つ世界的に認知された製薬企業
倫理的医薬品、OTC、再生医療における革新に注力
国際的な環境での協働を重視
全業務においてコンプライアンスと品質の卓越性を追求
キャリア成長とリーダーシップ開発の機会を提供
科学的専門知識と規制知識を重視
GMPおよびGQPの高水準維持に専念
職務内容
日本の規制当局(PMDA、MHLW)への申請用医薬品文書の作成
倫理的医薬品、OTC、再生医療に関する日本の規制を正確に理解し適用
規制およびコンプライアンス情報を海外クライアントに効果的に伝達
英文書やメールのレビューと迅速な対応
PowerPointなどを用いた英語でのプレゼンテーション作成・実施
製造拠点のGMP監査およびPMDA査察対応
QA申請文書のレビュー、変更管理、バッチリリース、QMS、SOP、ベンダー監査、市場クレーム対応
製造文書、逸脱、CAPA、変更管理を含むGQP業務の監督
第一種・第二種・再生医療等製品の販売業ライセンスのコンプライアンス維持
部門の目標設定、予算管理、スタッフ研修の主導
理想の人材
製薬業界でのQA業務経験10年以上
QAマネージャーまたは同等のリーダー職での経験3年以上
生物科学分野の大学卒業以上、博士号尚可
日本におけるGMP監査および規制コンプライアンスの実務経験
グローバルな協働に必要な優れた英語コミュニケーション能力
QMS、GQP、規制申請に関する実務経験
目標設定、予算管理、チーム育成におけるマネジメント経験
What's On Offer
競争力のある給与・福利厚生パッケージ
世界的に評価される製薬企業でのリーダー職
国際的なプロジェクトや規制環境への関与
専門的な成長とキャリアアップの機会
協働的で革新的な職場文化
Contact: Zach Itozu
Quote job ref: JN
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Tokyo Michael Page+グローバル製薬業界のコンプライアンスにおけるQAリーダー · + · +日本の規制当局(PMDA、MHLW)への申請用医薬品文書の作成 · 倫理的医薬品、OTC、再生医療に関する日本の規制を正確に理解し適用 · + · + ...
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