職務内容：
複数のGxP部門が利用するITシステムの構築・保守運用・改善を行うチームメンバーの一員として、ご経験に応じ以下の業務を担当いただきます。
・GxP ITシステムの保守・運用
・CSV/CSA活動の計画・実行
・関連部門と連携した課題解決
・ITシステムベンダーマネジメント、品質確保
・各種手順書の整備
・当局査察対応

【担当システム例】
・品質イベント管理、文書管理、教育管理など

職種の魅力：
このポジションでは、GxPITシステムの運用・改善・バリデーションを通じて、患者さんに安全な製品を届ける基盤づくりに直接貢献できます。
将来的にはCSV/CSAの中核人財、あるいは品質領域のデジタル戦略企画を担うキャリアも目指せます。
社内GxP部門、ITベンダー、グローバル関係者など多様なステークホルダーと協働しながら、規制対応だけでなく仕組みの改善・高度化にも関われる点が大きな魅力です。
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Background of recruitment：
As digitalization continues to advance, GxP-regulated systems are becoming increasingly important in the quality assurance domain. To further enhance the reliability of the GxP IT systems that support our quality assurance processes and to strengthen our ability to respond appropriately to evolving regulatory requirements, we are looking for a professional who can drive both IT operations and CSV/CSA activities. This role is not limited to routine system operation and maintenance; we expect the successful candidate to take the lead in advancing quality assurance while being involved across the entire system lifecycle.

Description of work:
As a member of the team responsible for the implementation, maintenance, operation, and continuous improvement of IT systems used across multiple GxP functions, you will be responsible for the following tasks based on your experience:

- Maintain and operate GxP IT systems
- Plan and execute CSV/CSA activities
- Collaborate with relevant departments to resolve issues and drive improvements
- Manage IT system vendors and ensure system quality
- Develop, revise, and maintain procedures and related documentation
- Support regulatory inspections and audits

Examples of systems in scope include:
- Quality event management systems
- Document management systems
- Training management systems

Position Features：
In this position, you will directly contribute to building the foundation for delivering safe products to patients through the operation, improvement, and validation of GxP IT systems.
In the future, you will have the opportunity to grow into a core professional in CSV/CSA or pursue a career in digital strategy planning within the quality domain.
A key attraction of this role is the opportunity to collaborate with a wide range of stakeholders?including internal GxP functions, IT vendors, and global counterparts?and to contribute not only to regulatory compliance but also to the improvement and advancement of systems and processes.