About the Role
多岐に渡るステークホルダー（厚生当局、グローバルＱＡ、製造販売業者、原材料供給業者、社内関連部署）と連携を取りながら、篠山工場の品質システムについて導入/運用の責任を持つ。
- 責任の範囲内で品質の側面とプロジェクトを管理する
- ノバルティス品質管理システムのGxP適合性とコンプライアンスを保証し、サポートする
- すべての生産およびテスト活動の監督、cGxPへのコンプライアンスを保証する（データインテグリティとeComplianceを含む）
- Operation Excellence改善プロジェクトをサポートする
- 厚生当局からの新薬におけるＧＭＰ適合性調査に対応する
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
必須要件
- 学士以上をお持ちであること
- ビジネスレベルの英語力をお持ちであること。流暢な日本語力（読み書き、会話）
- 品質保証または品質管理の経験3年以上（他業界も可）
望ましい要件:
- 薬剤師資格をお持ちであれば尚可
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our
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people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You'll receive
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/ja_JP/network
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.
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
Division
Operations
Business Unit
QUALITY
Location
Japan
Site
Sasayama
Company / Legal Entity
Novartis Pharma K.K.
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No