Advanced QA for External Production at CMO
4 days ago
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Advanced QA for External Production at CMOCategory: Quality
Location:
Søborg, Capital Region of Denmark, DK
Do you want to work in one of the most interesting and challenging areas in Novo Nordisk? Are you passionate about Quality Assurance and Quality Management Systems (QMS)? Are you eager to take your professional career to the next step and want to have international business impact?
If yes and you are ready to make a difference for millions of patients, read more and apply now
The job
In this position as Advanced QA, you will work with Contract Manufacturing Organizations (CMOs) located around the world. The objective of the position is to ensure QA oversight by activities such as visits at the CMO, compliance checks, approval of QMS documents and release of Novo Nordisk insulin products to the market.
You will, as an Advanced QA, together with a highly skilled QA team, be responsible for delivering best-in-class Quality Assurance and work with our colleagues in Line-of-Business to ensure the highest quality at our CMOs production.
Your main responsibilities will include:
- Together with your QA team, handle daily operations such as approval of change requests, deviations and batch release, as well as supporting in all quality matters.
- Building the Quality mindset as well as Quality and Compliance culture at the CMO.
- Training the local CMO QA organization to maintain and improve compliant operations.
- Engaging and energizing local employees at the CMOs.
At present, approximately 3 weeks of travel per year to one of the CMOs is expected.
Qualifications
We are looking for a colleague who can handle situations independently, apply subject matter knowledge, identify better practices, create improvements to processes, share knowledge, and let colleagues learn and shine.
To succeed in this role, you:
- Hold an academic degree within Pharmacy, Chemistry, Biochemistry, Biotechnology Engineering or similar.
- Have some relevant experience working with either aseptic processes, assembly or packaging production in organizations within pharmaceutical manufacturing (either as QA or production).
- Have a high level of knowledge within Quality, QMS and EU GMP requirements.
- Have gained said experience within the pharmaceutical or medical devices industry.
- Are fluent in English, both written and spoken.
As a person, you have a high level of energy and drive, are open-minded with a positive attitude, want to make a difference, and are eager to learn.
As we operate in an international environment, often with cultural and political challenges, you come with respect for cultural differences, are diplomatic, and have a mature appearance and style which demonstrates authority and good judgment.
About the department
The position will be part of the organizational set-up in Global Contract Manufacturing Drug Product - QA Operations – Finished Product Local CMO (LCMO QA) is a part of External Supply in Product Supply, Novo Nordisk A/S.
We are responsible for Quality Assurance of Novo Nordisk's local manufacturing CMOs; we currently consist of eight QA colleagues working closely together, covering our operational CMOs in Saudi Arabia, India, Bangladesh and soon to come South Africa.
One of the primary roles of LCMO QA is to deliver QA support and set direction for CMOs, who deliver a variety of diabetes products to their local markets, covering different processes ranging from aseptic manufacturing, inspection, QC, assembly, and packaging, in countries where local presence is required to maintain market access.
The job is in Høje Taastrup, Denmark. Things move fast in our unit, and the daily operation is dependent on cooperation with many internal and external stakeholders from all over the world.
Working at Novo Nordisk
At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop; we seize them. From research and development, through to manufacturing, marketing, and sales – we're all working to move the needle on patient care.
Contact
For further information, please contact Senior Quality Manager Asger Laurberg Vig at +45 30752770.
Deadline
5 January 2024
We will review applications received on an ongoing basis, so do not hesitate to apply today.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds, and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in. Together, we're life-changing.
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