Associate Compliance Expert
il y a 6 jours
100+ external suppliers for the Puurs site. A Quality Compliance Expert ensures quality of the materials used to produce finished products and supplier our patients. And supports effective GxP Compliance and/or Audit activities to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements
Your responsibilities:
- Support the preparation and management of external and corporate audits and Health Authority inspections.
- Support site qualification and validation activities (planning, advising, review)
- Implementation of Quality Systems (incl. documentation management)
- Supplier management activities (agreements, oversight, audit)
- Preparation/support & coordination of Corrective and Preventive Actions (CAPA)/follow-up Change control review/approval
- Ensure local Data Integrity and e-Compliance oversight (training, inspections, plan, risk ID etc)
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable) Focus on supplier quality assurance
**Commitment to Diversity & Inclusion**:
- We are 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:
- 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 Dutch. Good knowledge of English
- Good experience in working with external supplier & internal partners.
- Good communication skills, accurate, out of the box thinking, structured and standout colleague
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.
**Division**
Operations
**Business Unit**
QUALITY
**Country**
Belgium
**Work Location**
Puurs
**Company/Legal Entity**
ALCON BEL
**Functional Area**
Quality
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
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