QA Validations Professional

Are you interested in joining an exciting journey of innovation that involves implementing new assembly and packaging lines across the globe for Novo Nordisk? Do you possess a strong quality-oriented mindset and excellent interpersonal skills that can contribute to a significant impact on Quality Assurance? Are you someone who thrives when working on projects?
If so, there is a challenging and exciting job opportunity in Fill & Finish Expansions FP QA at Lyngby, and you could be the QA professional that we are seeking!

The Position
As a member of a newly established department, your responsibilities will mainly consist of overseeing validation activities of all new assembly and packaging lines worldwide and approving documentation. Additionally, you will be involved in one or more projects, working closely with QA colleagues and stakeholders across the world within DMD (Device Manufacturing Development) and local sites to ensure the implementation of new FP lines with the highest quality in mind for the patient. 
Your responsibilities within the newly established department will include:
• Overseeing validation activities of all new assembly and packaging lines worldwide and approving documentation.
• Reviewing and overseeing various documents related to validation and qualification to ensure compliance with current GMP rules and guidelines and to maintain product quality.
 

Our location in Lyngby offers a flexible work schedule allowing you to plan your daily tasks and work from home when suitable for the operation and your team. Additionally, international travel will be required particularly related to vendor oversight.
Novo Nordisk offers professional growth opportunities in a challenging yet supportive environment. As a QA Validations Professional in Fill & Finish Expansions, you can develop competencies in overseeing global assembly and packaging line validation. The company supports employee development through training programs, encouraging ownership of work and significant impact on Quality Assurance.

Qualifications
To thrive and succeed in this role, you should have:
• Experience with validation and qualification, preferably as a QA person.
• Experience in assembly and/or packaging production in the pharmaceutical industry.
• Risk-based approach and the ability to balance compliance and product quality.
• Strong quality mindset and result orientation.
• Excellent skills in collaborating with stakeholders from different cultures and organisational levels.
• Preferably a master’s degree in pharmacy, chemical engineering or similar.
• Proficiency in English, speaking and written.
 

As a person, you are positive, cooperative and solution oriented, and you are not afraid of taking charge. Furthermore, you work systematically, logically, and proactively. You thrive in a dynamic environment where cooperation with many different stakeholders will be crucial to your success.
 

About the Department
The Fill & Finish Expansions FP QA department is a newly established part of Fill & Finish Expansions QA. As part of this area, we play a key role in major expansion projects aimed at increasing aseptic and finished production capacity across the Novo Nordisk network. Our goal is to ensure that we continue to deliver high-quality products for our patients, even in the future.
We want to rethink the way we implement aseptic and finished production and build something we can be proud of, even 20 years from now. Our department is responsible for ensuring quality assurance and compliance with new facilities. We work closely with our stakeholders to maintain a high level of quality and compliance with GMP.
As a member of our area, you will work in a vibrant and positive environment that values the exchange of knowledge and experience. Networking and cooperation are key to our success.