We are looking for a Responsible Person to provide quality oversight and ensure compliance with Wholesale Distribution Licence requirements and Good Distribution Practice (GDP) regulations. This role plays a critical part in maintaining the highest standards of quality, compliance, and patient safety.,
- Act as the Responsible Person for designated Norgine entities and Wholesale Distribution Licences.
- Ensure compliance with EU GDP requirements and applicable regulations.
- Lead inspection readiness activities and support regulatory inspections.
- Oversee outsourced distribution activities and third-party compliance.
- Support product recalls, investigations, audits, and risk management activities.
- Develop and maintain quality procedures, policies, and training programmes.
- Provide expert advice to internal stakeholders on quality and compliance matters.
- Drive continuous improvement across quality and distribution processes.
Scientific Bachelor's degree or equivalent qualification. - Eligible for immediate registration as a Responsible Person.
- Experience within pharmaceutical GDP-regulated environments.
- Experience conducting audits and supporting regulatory inspections.
- Strong knowledge of quality systems, regulatory compliance, and risk management.
- Excellent planning, organisation, and communication skills.
- Ability to make sound decisions and manage complex issues effectively.
At Norgine, we have been transforming people's lives for over a century. We are a leading European specialist pharmaceutical company, combining deep expertise, an integrated infrastructure, and strong partnerships to bring life-changing products to patients.
Our values are at the heart of everything we do: Drive - We take ownership, make timely decisions, and deliver results. Dare - We challenge respectfully, encourage innovation, and embrace new opportunities. Develop - We collaborate, value different perspectives, and help people reach their full potential., At Norgine, we support multidimensional careers where people are encouraged to dare, drive and develop. You'll join a collaborative organisation committed to improving patients' lives while providing opportunities for professional growth, learning, and meaningful impact.
#J-18808-Ljbffr
Quality Compliance Officer & Responsible Person (RP) in Uxbridge employer: Norgine B.V.
Norgine B.V. is an excellent employer that fosters a collaborative and innovative work culture, where employees are empowered to make a meaningful impact on product quality and compliance. Located in a dynamic environment, the company offers robust growth opportunities through professional development and training, ensuring that team members can advance their careers while contributing to the success of the Global Quality Team. With a strong commitment to employee well-being and a focus on teamwork, Norgine provides a rewarding workplace for those passionate about quality assurance in the pharmaceutical industry.
