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GMP Coordinator

2 months ago


Kalundborg, Denmark Novo Nordisk AS Full time

Are you well-versed in Good Manufacturing Practice (GMP) and driven by the challenge of setting high compliance standards while continuously improving processes? Do you have the ability to act as a role model in setting the direction? If yes, then you are the perfect fit for our GMP Coordinator position in the Packaging department in Kalundborg, Denmark.
Read on and apply below for this exciting opportunity at Novo Nordisk.


The Position
As a GMP Coordinator at Novo Nordisk site in Kalundborg you will be at the heart of a dynamic environment where no two days are the same. In this role you will be the driving force behind our commitment to excellence in haemophilia production. You will juggle coordination, follow-up, and strategic direction-setting, while pushing forward key actions and projects across the department. Your ability to stay flexible, prioritize effectively, and manage your time will be crucial as you balance these diverse responsibilities alongside your own tasks.


Your main responsibilities in this role will include: 

Driving the preparation and overseeing the follow-up on authority inspections and internal audits. Coaching and assisting your colleagues in GMP-related tasks such as deviations, changes, projects etc. Preparing trend reports, Quality Oversight Tools, Quality Management Reviews (QMR). Maintaining a high-level GMP overview and reporting on GMP and quality trends to management. Leading with vision and driving projects to success.

But that is not all – you will also be an essential member of the GMP network within the CVP area. Here, you will have the opportunity to foster collaboration, align goals, and share best practices. If you are energized by the prospect of making a broad impact while driving both team and individual success, this is the perfect role for you.


Qualifications
On a personal level, you are positive, action-oriented, and thrive in a cooperative environment. You approach challenges with a solution-focused attitude, working systematically and proactively. Your communication skills enable you to connect with everyone from operators to management, and you are proud of your ability to tackle tasks hands-on, ensuring that the key stakeholders are engaged and involved throughout the process.


To excel as our GMP Coordinator we expect you to have:

A BSc or MSc degree in pharmacy, biology, engineering, or a related field.  Minimum four years of experience in process support, packaging or QA in the pharmaceutical, medical device or similar regulated industry. Strong experience and skills in GMP-regulated environments and complex production processes. The ability to see the big picture while never losing sight of the critical details that make all the difference. A mindset which is rooted in LEAN principles, and experience in systematic problem-solving, always looking for ways to improve efficiency and effectiveness.  Fluency in both Danish and English, allowing you to communicate seamlessly across our organization.


About the Department

We are a part of Finished Production Manufacturing DK-2 with approximately 100 people employed, working together to ensure that our finished products are packed to the highest standards before distributed to people living with serious chronic diseases. We bring value to our patients by delivering high-quality products in accordance with Good Manufacturing Practice (GMP) in a timely and cost-effective way as we constantly optimize our processes and invest in the latest technology.