345728BR
Jun 21, 2022
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.

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

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. Operational Exellence (OpEx)
・Lead OpEx project in Japan
・Japan representative for Project lead by Global
・Japan representative for quality operations led by Global
4. Compliance
・Compliance data delivery
・Support to maitain the mechanism of quality risk assessment
・Lead local task/initiative to maintain compliance to new local regulation including pharmacopoeia update
・Vender management (e.g. Quality Ageement, risk assessment)
5. Cross-divisional support
・Internal GxP audit facilitation
・HA Inspection support
・Data Integrity
・E-compliance
・Quality initiatives



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

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Education:
Bachelor of Science or equivalent

Experience/Professional requirement:
1. Knowledge of the PMDAct and related regulations
・cGMP / GQP / GCTP / GDP / QMS
・ICH guidelines
・Novartis Quality Manual
2. Knowledge of quality for pharmaceuticals, medical devices and human cell therapy / gene therapy products
3. Knowledge of Novartis products
4. Person who has engaged in the quality assurance duties or other similar duties for at least three (3) years
5. Complete all necessary training for Qulaity IT system operations
6. Complete the Investigator Certification Program defined by Novartis Training business unit

English Skill: Business Level (writing, speaking)
Novartis Technical Operations
NTO QUALITY
Japan
Tokyo
Quality
Full Time
Regular
No
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345728BR

Associate, Quality Operations and Compliance

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