柔軟な働き方とキャリアアップの機会が豊富
企業情報
世界中の人々の健康と生活の質を向上させることを使命とするグローバル製薬企業。革新的な医薬品開発に注力し、品質と安全性を最優先に取り組んでいます。
職務内容
APAC地域でのGCP監査の計画・実施・報告
監査結果に基づく是正・予防措置(CAPA)の推進
リスクベース監査の準備・実施
PMDA適合性調査への対応
年間監査プログラムの管理(Veeva Vault QMS使用)
QAシステム改善や新技術導入の推進
理想の人材
BS/BA学位または同等の資格
製薬企業またはCROでのGCP監査経験(5年以上)
ICH-GCP、PMD法、FDA/EMA規制の実務知識
条件・待遇
ハイブリッド勤務制度
グローバルプロジェクトへの参画機会
キャリア開発プログラム
健康保険・各種社会保険完備
ワークライフバランスを重視した環境
Contact: Kao Toyama
Quote job ref: JN
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