Manager, Commercial GMP QA

326707BR
Sep 02, 2021
Japan

Job Description

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.

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
Timely management of periodic regulatory compliance check including APQR review
Timely management of periodic GMP inspection certification for Novartis products related manufacturing sites and others
Update existing system and process reflecting new requirements from HA and others
4. Quality improvement - Contribute continuous quality improvement in collaboration with relevant business units, manufacturing sites and others
5. Support projects such as new product launch, product transfer, global and/or local initiatives
6. Contribute to operational integration with Sandoz Japan for operational excellence and simple operation
7. Ensure appropriate interface with authorities for any GxP related activity and provide individual responsibility as a SPOC for health authority if requires.


Minimum Requirements

応募資格 :
Education:
Bachelor of Pharmacy or equivalent

Experience/Professional requirement:
1. Knowledge of the PMDAct and related regulations
- cGMP / GQP / GCTP / GDP / QMS
- ICH guidelines
- Quality Manual/Quality Directive

2. Knowledge of quality for pharmaceuticals, medical devices and human cell therapy / gene therapy products

3. Knowledge of products

4. Person who can engage quality assurance duties properly and efficiently, approved by Quality Assurance Supervisor

5. Complete all necessary training for QA IT system operations

6. Complete the Investigator Certification Program defined by Novartis Training business unit

Language:
• More than 800 score of TOEIC
• Business level English(writing, speaking)
• Local Language Required

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
Novartis Technical Operations
NTO QUALITY
Japan
Tokyo
Quality
Full Time
Regular
No
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326707BR

Manager, Commercial GMP QA

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