Country Quality Manager
6 days ago
Job ID REQ-10035063
Jan 10, 2025
SummaryThe Country Quality Manager - QP, RP is responsible for the assurance that the product quality conforms with specifications and that production activity is compliant with Novartis quality policy and GxP requirements. The Country Quality Manager ensures that relevant documentation is up-to-date and archived correctly. Ensure “state of the art” GxP know-how and future trends in the field of GxP. The Country Quality Manager acts as the Responsible Person (RP) for Novartis Healthcare A/S, Denmark and as the Qualified Person (QP) for Novartis Country legal Novartis Healthcare A/S, Denmark, ensuring that Novartis operates in compliance with any applicable regulations (GMP & GDP).
About the RoleMajor accountabilities:
- Act as the Responsible Person, RP, for all requests related to Novartis Healthcare A/S GDP activities
- Ensure compliance with and implementation of EU GDP and local GDP regulations
- Responsible for the import control of medicinal products imported with the wholesaler license of Novartis Country legal entity
- Coordinating and promptly performing any recall and mock recalls for medicinal products
- Act as the Qualified Person for Novartis Healthcare A/S
- Assure local compliance with and implementation of EU GMP and local GMP regulations
- Ensure QP approval of local manufacturing activities performed during the importation of medicines from third countries
- Release commercial medicines for distribution after QP certification
Qualifications:
- Masters Degree in Pharmacy or related Life Science fields.
- Eligible to be approved as Responsible Person by local Health Authority for WDA license. Eligible to act as Qualified Person (QP). EU QP qualifications must be effective and recognized by local regulations.
- 5+ years 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. Knowledge of Danish is highly preferred.
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
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.
DK06 (FCRS = DK006) Novartis Healthcare A/S
Functional Area Quality
Job Type Full time
Employment Type Regular
Shift Work No
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