Associate, Country QA Operations, Core Products

品質保証の業務は多岐に渡りますが、患者様のお手元に医薬品を届けるためのキーパーの役割を担っています。その中でも製品品質保証部のコア製品品質グループはノバルティスの多様な医薬品の製品に特化した管理（変更管理、逸脱管理、品質情報）を主軸として、社内外や海外の関係者と日々多く関りながら、製品品質の維持と向上を目指しています。製品の品質を保証するための、活動は決して容易ではありませんが、チームメンバー同士が支え合えながら皆で達成の喜びを分かち合うアットホームな環境です。

Job Purpose:
Based on Novartis Quality Manual and Policies, the following are achieved under local regulations.
• Stable supply to high quality products
• Keep regulatory compliance under cGMP / GQP / GCTP / GDP / QMS and related local regulations
• Satisfy customers from quality point of view

Major Accountabilities:
1. Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
2. 100% timely delivery of all training requirements including compliance
3. Manage the following regulatory compliance activity under GQP/QMS Work together with other line functions by receiving necessary advice from other NCQ member to keep the compliance of Japan approval files for the products
 Oversight GMP manufacturing sites from GQP point of view
 Entering into quality agreement with manufacturing sites, business partners and maintain it
 Change control related to product quality
 Deviation and CAPA management
 Technical complaint management
 Timely management of periodic regulatory compliance check
 Update existing system and process reflecting new requirements from HA and others. Reduce complexity and simplify the operational process.
4. Quality Management System
 Implement and maintain the local Quality System in GxP areas, in accordance with the Novartis Quality Manual, the NCQ-J Quality Plan, and the local regulatory requirements through:
 Implementation of global quality documents in the Japan Country
 Contribution to the NCQ-J Quality Plan preparation, implementation and follow-up
 Contribution to the Quality Risk Assessments
5. Quality improvement
 Contribute continuous quality improvement in collaboration with relevant business units, manufacturing sites and others
 Contribute to reduce product quality complaints by improvement of product quality
 Manage deviations through proper investigation, CAPA implementation, effectiveness check and trend analysis by receiving necessary support from NCQ member or Quality supervisor
6. Support projects such as new product launch, product transfer, global and/or local initiatives
7. Ensure appropriate interface with authorities for any GxP related activity and provide individual responsibility as a SPOC for health authority if requires.

Why consider Novartis?

817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。
約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。
ノバルティスファーマ株式会社は、スイス・バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis.co.jp

Japan
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.
ノバルティスは障害を持つ個人と協力し、合理的配慮を提供することをお約束します。
健康状態や障害を理由に採用プロセスのいかなる部分においても、あるいは職務の必須事項を果たすために合理的配慮が必要な場合は [email protected]宛てに電子メールをお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してください。