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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
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
