Would you like to use your hands on knowledge about GMP in the production, both to help with concrete tasks as well as using your experience to drive and improve our work with GMP? Do you enjoy working with different people from different fields of expertise to develop good standards as well as help with everyday problems in an agile multipurpose API facility? If yes, we encourage you to apply for this position!
We are looking for a senior GMP coordinator in our API production (Active Pharmaceutical Ingredient) Hillerød. The production has two facilities which produce 3 different products, sharing the responsibility around this in 4 different departments.
The Position
Your role will be to maintain and improve our state of compliance with regards to DV handling, audit setup and general tasks around our compliance requirements. You will have the opportunity to collaborate with other quality coordinators in our area to handle tasks across the area, e.g. focusing on improving performance on quality KPI’s or the work with signals in different processes.
Your tasks will include:
• Plan, Prepare, handle and follow up on authority inspections and internal audits in 25K.
• Drive and coordinate quality improvements in 25K
• Responsible for GMP training and contribute to the understanding of GMP in 25K
• Responsible for delivering and analyzing data to support production KPIs
• Drive and participate in quality or compliance related projects and contribute to optimization of quality processes in 25K and across the CVP area
• Fill the role as Data Integrity Steward in the ongoing Novo Nordisk Data integrity project
A normal day could look the following: After checking your calendar you plan your day. On the DV reduction board you want to present the results of your latest project on double controls. You also need to prepare a few charts for the compliance board, which you run for the whole facility. Later in the afternoon there is scheduled an A3 meeting with the Upstream Support Team. You will pop in for some sparring on one of the complex deviations they are working at
Then you check your mails; great, the cross organizational working group for GMP supporters have planned their next meeting. The topics about simplicity and compliance as well as rolling out of the new DV SOP sound really interesting to you! Also, you receive the information that the new audit plan is communicated. You make a note to yourself to inform the management group about the dates and start the standard KPI for audit preparation you have already developed on the compliance board. Then you dash off to grab a cup of coffee and start you work…
Qualifications
To be considered for this position you must have:
• An academic degree (BSc or MSc) in natural science, engineering or similar.
• Preferably +5 years of experience from similar position within Novo Nordisk.
• You are familiar with complex quality processes and have experience from Good Manufacturing Practice (GMP) regulated areas.
• Experience with ISO and/or LEAN is an advantage, as it is an integral part of our everyday work.
• Proficiency in both English and Danish is a requirement.
On a personal level you thrive and get motivated by working with and across multiple levels in the organization, whilst you are known for your excellent collaboration and communication skills and ability to set direction. You are solution oriented and work systematically, proactively and strive for simplicity in processes, while taking pride in solving your tasks and challenges as close to the process as possible, with close involvement of your stakeholders.
About the Department
You will be part of a dynamic business area that produces Active Pharmaceutical Ingredients (API) for patients across the world.PS-API M4 is an area in Novo Nordisk that will be at the centre of many new initiatives in the coming years. We manufacture a range of innovative products for our patients living with diabetes, haemophilia, hormonal imbalances and other impactful chronical diseases. API Manufacturing 4, 25K Multi Product Facilities consists of around 200 employees split into different teams and staff function. We are situated in Hillerød and produces various APIs which are used to treat patients all over the world.
About Site Hillerød
Site Hillerød is an innovative and fast-growing production site. With over 4,000 talented employees, we work together to drive change for people living with serious chronic diseases. The site is located in beautiful natural surroundings, and we offer a diverse array of career paths at all educational levels. Join our vibrant community at Site Hillerød and ramp up your career while we ramp up our production! Get to know us better - visit our Site Hillerød career page. Novo Nordisk Hillerød
Contact
If you would like to know more about the position, please contact Senior Manager, Christiane Wiendahl, on +45 30794862.
Deadline
16 February, 2025. But we are reviewing candidates on an ongoing basis, and we will close the selection process once we have the right candidate.
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 communities we operate in. Together, we’re life changing.