Country Quality Specialist, QP Delegate/RP Deputy

Job Description Summary
The Country Quality Specialist, QP Delegate/RP Deputy manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems. Furthermore, this role includes:
- Acting as QA Manager for Novartis Country Quality in Denmark for GMP/GDP related activities.
- Acting as the Qualified Person (QP) delegate for Novartis Healthcare A/S
- Acting as Responsible Person (RP) deputy for Novartis Healthcare A/S

Job Description
Major accountabilities:

• Release commercial medicines for distribution after QP certification
• Ensure that CoCs/CoAs and other documents are reviewed and archived for all batches released for sale
• Ensure escalations of GMP related issue.
• Act as the Responsible Person deputy for the Wholesale Distribution Authorization in Denmark
• Coordinating and promptly performing any recall and mock recalls for medicinal products
• Ensure that Product Technical Complaints concerning Novartis products are appropriately reported and investigated according to regulation.
• FMD alert handling oversight
• Report stock outs to Country Agency

Minimum Requirements:

• Education: Degree in Life Sciences or related fields. Eligible to act as Qualified Person (QP). EU QP qualifications must be effective and recognized by local regulations.
• At least 1 year of experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, clinical development, or production or a directly related area.
• Solid GxP knowledge
• Quality mindset, analytical approach, self-driven and collaborative
• Fluent English, written and spoken

Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Skills Desired

Location: Copenhagen