Qualification and Project Coordinator

Are you passionate about qualification and project coordination of equipment implementation? Are you eager to be part of Novo Nordisk’s major quest within tablets and join our newly established Emerging Technologies area? If yes, you are the Qualification and Project Coordinator that we are looking for, read more and apply now!

About the Department
Oral Product Development (OPDev) is an area within Product Supply, Quality and IT, which employs approximately 280 highly skilled people organised in five departments and is based in Måløv. Our focus is to develop and manufacture solid dose tablets for pre-clinical and clinical trial phases I, II and III, covering a broad and exciting range of process technologies for solid dosage forms.

OPDev Technical Support department consists of two teams: Team 1, IT & Quality and
Team 2, Equipment & Facility, whose responsibilities include qualification of equipment, facility monitoring, maintenance and calibration. We are currently expanding our Facility & Equipment team, consisting of 18 dedicated colleagues all contributing to sustain our “License to operate”.

The Position
In this role, you will be responsible for supporting the structures around both minor and major investment projects, as well as monitoring and controlling the project activities. Therefore, you will have a close collaboration with internal and external stakeholders such as Production scientist, Development scientists, Skilled workers, Quality Assurance, and various cross functional Process Groups, ensuring that our project timelines and deliverables are met.

Among your responsibilities, you will:
• Optimizing our incoming equipment flow from stakeholder requests
• Implement and qualify new and existing equipment 
• Ensure that equipment and facilities are following GMP standards
• Ensure that system documentation is in place.

Responsibilities like qualification of equipment, utilities and facility are an absolute essential part of our ability to produce in compliance with GMP standards, so you will be able to play a key role in making sure our patients have access to our products with the highest standards.

Qualifications
• You have a Bachelor or Master´s degree within Engineering or Pharmacy or any other relevant education
• Preferable you have more than 3 years of experience with project management and/or qualification of production equipment in the pharmaceutical industry.
• You are proficient in written as well as spoken Danish and English.
• Knowledge within solid dosage forms may be an advantage but it’s not a prerequisite
 

On a personal level, you are a good communicator, who shares knowledge to strengthen the overall abilities of our team. You dare to take the lead, even when the task initially is not fully scoped and have a good approach to structure when it comes to planning and executing on tasks.