Associate, Investigation Expert ,Sasayama " >Associate, Investigation Expert ,Sasayama

329628BR
Oct 12, 2021
Japan

Job Description

Through the partnership with more than 1000 external
suppliers, our network of 7 technology platforms
provides our customers and patients in more than 150
countries with innovative, high-quality and affordable
products on time, every time, safely & efficiently.

Your Responsibilities;
-Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity & eCompliance -Support exception investigations -Review & approval of production, QC, and AS and T records
-MBR review -Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration.

1. 品質保証業務
・逸脱管理全般
逸脱記載内容の確認・調査結果のレビューおよび承認
バッチの処置についての判断及び製造元への連絡と協議
逸脱記録の進捗確認、傾向分析の実施、報告
CAPAの計画レビュー・進捗管理・作業結果承認と有効性確認
国内、海外製造品の製造元への逸脱連絡・品質改善・CAPA確認
技術会議の実施
不良サンプルの海外への送付
バリデーション文書の照査、製造工程手順書・MBRの承認

2. 法律及び規則の遵守
・GMP/GCTP/QMSコンプライアンスの確保
・承認事項/各種法令又は通知等へのコンプライアンス確保
・コンプライアンスの徹底、HSEの遵守/改善
・QM/QDコンテンツの手順書への落とし込み

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

What you’ll bring to the role:
-Manages Quality aspects & projects within area of responsibility.
-Ensures and supports overall GxP conformity & Compliance with the Novartis Quality Management Systems
Desirable requirements:
・Collaborating across boundaries Functional Breadth QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & cleanliness zones English
・Quality Control (QC) Testing Knowledge of GMP Knowledge of IT Applications & tools Quality Standards Quality Assurance
・English:TOEIC 700Over
・Japanese:Business Level(NT-1)


1. 薬機法/GMP/GCTP/QMSに関する専門知識
・薬機法/GMP/GCTP/QMS関連法規及び通知/日本薬局法
・ICH/PICS/cGMP
2. 製造管理及び品質管理に係る業務の熟知
3. Helth,Safty and Emviromentに関する法規制に対する知識
4. 組織マネジメントに関するビジネススキル
5.英語:TOEIC700-800,日本語:ビジネスレベル

About Novartis Japan:
Novartis Pharma KK operates as a pharmaceutical company. The Company develops, produces, imports, and sells prescription drugs, over-the-counter medicines, and health-care products. Novartis Pharma's products are used in cardiovascular, cancer, respiratory, and central nervous systems.
Workplace benefits:
Attractive office location, flexible time management, strong work/life balance, flexible working hours, truly multinational and dynamic organization, multicultural environment and cross-functional hub location
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Why consider Novartis?
799 million. 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.
Imagine what you could do at Novartis!
Novartis Technical Operations
NTO QUALITY
Japan
Sasayama
Quality
Full Time
Regular
No
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329628BR

Associate, Investigation Expert ,Sasayama

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