Associate, Country QA Operations, Core Products

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.

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 midcareer.japan@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

midcareer-r.japan@novartis.com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。