About the Role
立ち上げフェーズの中核として、機器導入の手配、製造プロセスバリデーション詳細確認と翻訳レビューなど、試験方法、仕様、分析基準の実施に関する実務を担う。安定性試験、モニタリング、トレンド調査を含め、担当領域内の製品（開発中、移管中、商業化中）のcGxP基準へのコンプライアンスを確保する
• 新規ラボの立ち上げに際し、手順書を作成し、機器を導入する。
• 品質、コスト、人材、納期に関するターゲットを達成したうえで、GMP（医薬品の製造管理及び品質管理に関する基準）及びライセンス要件に従い、タイムリーに納品する。
• グローバル組織と協働して試験方法を海外から導入し、会社の要件を満たしつつ日本で採用する。
Diversity & Inclusion / EEO
私たちは、優れたインクルーシブな職場環境の構築、および患者様や地域社会を代表する多様なチーム作りに取り組んでいます。
Role Requirements
必須要件
• 医薬品の品質管理の経験3年以上
• 学歴不問
• 日本語力 (母国語レベル)
• 英語力 (ビジネス初級レベル) 海外出張の可能性あり
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放射線製剤の知識があれば良い
Want more jobs like this?
Get Business Operations jobs in Sasayama, Japan delivered to your inbox every week.
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
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
篠山
Company / Legal Entity
Novartis Pharma K.K.
Job Type
フルタイム
Employment Type
正社員
Shift Work
いいえ