Associate, Country QA Compliance

Country QA Complianceは、品質統括部門の中で新製品開発プロジェクトへの参画と製造所に対するGMP適合性調査業務を行う部署です。本Roleでは、新製品開発プロジェクトの中で薬事部門や国内外の製造所、サプライグループ等と協働しながら、新薬発売に貢献することができます。GMP適合性調査業務では、新規申請、及び一変申請に伴うGMP適合性調査、並びに５年ごとに実施する定期GMP適当性調査につき、申請～結果通知受領までの当局対応を行います。海外製造所等の担当部門及び当社の篠山工場等の国内製造所とのコミュニケーションを通して、申請に必要な資料の入手、確認や当局への申請及び照会対応業務を行います。また、当局による実地査察の際には当該製造所への訪問などを通じて幅広い経験ができるポジションです。

GMP適合性調査業務の経験のある方、新たなキャリアとしてQA業務に挑戦してみたい方からのご応募をお待ちしています！

Job Purpose :

Based on Novartis Quality Manual and Policies, the following are achieved under local regulations for Innovative Medicines

• Maintain regulatory compliance under GxP / QMS and related local regulations
• Stable supply to high quality products
• Satisfy customers from quality point of view

Major Accountabilities :

1. Compliance

Regulatory Compliance

PMDA GMP Compliance Inspection (Paper based / On-site inspection)

Lead local task / initiative to maintain compliance to new local regulation including Pharmacopoeia update

2. Cross-functional support & Stakeholder management

NPI (New product Introduction)

BD&L (Business Development & Licensing) Project

Support of Routine Quality Operation

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.

8億人以上の患者さんに世界中で届けられています。

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。

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.

[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。