Summary
品質に関するすべての事項において、サイト／サプライヤーの戦略的• 経営的リーダーシップを発揮し、業務上の重要な側面がcGxPに準拠していることを確認する。グローバル組織と協働し、会社の要件を満たしつつ日本の規制に準拠した形で導入する。
About the Role
主な役割責任
- 責任範囲内の製品（開発中、移管中、商品化中）および製品リリースにおけるcGxP基準への準拠を確保する責任を負う
- 立ち上げフェーズの責任者として、法的要件に沿った建屋、品質保証体制の設計、無菌製剤の製造におけるSOPを明確化する。
- 製品品質を担保するため、社内の利害関係者および外部ベンダーとの強固な関係を構築する。
必須要件
- 無菌製剤の品質保証知識と経験３年以上
- 学歴不問
- 日本語力 (母国語レベル)
- 英語力 (ビジネスレベル) メール30-40％ / MTG 20-30%に参加する
望ましい要件:
- 放射線製剤の知識があれば良い
- Curious、Inspired、Un-bossedの企業文化を理解し、リーダーと社員が期待されることを認識しつつ、自ら進んで企業文化を推進できる方。
- 自分が分からない範囲であったとしても、学んで自ら対応しようとする自主性の高い方
At Novartis we thrive together
Throughout your career here, you'll be recognized for your contribution, celebrated for your achievements, and valued for who you are. The rewards of being part of our team go far beyond pay and incentives. From learning and development to health and wellbeing. From flexible working to volunteering opportunities. We support you to be at your best, at work and in life
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Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Operations
Business Unit
Innovative Medicines
Location
Japan
Site
Sasayama
Company / Legal Entity
JP99 (FCRS = JP005) Ciba-Geigy Ltd.
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No