Compliance scientist

328082BR
Oct 01, 2021
Belgium

Job Description

5-7 products manufactured at the Puurs site. A compliance scientist typically is responsible for regulatory compliance life cycle management of these products. If your’re also involved in a new product, you’ll oversee the QA aspects of the new product throughout the full process from first transfer steps into the site until commercial launch in up to 80 countries.


Your responsibilities:
Your responsibilities include, but are not limited to:

• Responsible for regulatory compliance, you play an important key role to ensure product of the requested quality is delivered to our patients. Only after regulatory approval, which is required for every individual country, a product can be delivered to the concerned markets and this is needed to allow the treatment of patients with our pharmaceutical products.
• Liaison between Reg CMC, R&D and NTO Puurs site departments. Main responsibilities are supporting regulatory submissions, Health Authority Questions, and ensuring regulatory compliance through the implementation of registered information (CPDS, LIMS).
• Within the general responsibilities of QA Compliance, the specific responsibilities of this QA Compliance Specialist are: supporting QA Compliance related launch and post-approval activities (post-approval changes, transfers of new products, regulatory compliance support for changes, remediation, divestment, pruning and due diligence) of the site specific products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements

Minimum Requirements

What you’ll bring to the role:

• Knowledge of Core work processes Quality Standards and Quality Assurance
• Working experience within the pharmaceutical industry preferably Quality
• Bachelor or Master in Sciences (e.g. pharmaceutical sciences, biomedical sciences, bio-engineer,...)
• Knowledge of GMP
• Excellent knowledge of English. Good knowledge of Dutch or willingness to learn
• Good experience is working with cross functional teams
• Good communication skills, accurate, out of the box thinking, structured and teamplayer

You’ll receive:

We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Novartis. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Novartis also supports a flexible work-life integration (working remotely, flexi-time schedules, ...). Your office will be based in Puurs. Locally, we offer benefits to ensure our associate's mental and physical well-being. There is a fitness available for our associates to use and we offer a bike-leasing program. We have a mental coach on site as well.

Why consider Novartis?

769 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!


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.

#LI-NOV
Novartis Technical Operations
NTO QUALITY
Belgium
Puurs
Quality
Full Time
Regular
No
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328082BR

Compliance scientist

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