Quality Assurance SME - Kalundborg, Danmark - Novo Nordisk

Beskrivelse

The position
We are looking for a Quality Assurance SME

• GxP Regulated Facilities within the areas of design and qualification of classified areas as well as supporting HVAC systems (Manage GxP Regulated Facility).

You will be part of a highly experienced team whose main focus is to ensure the right level of compliance in strategic projects, redesign existing facilities, and build innovative facilities for the future. Quality Assurance SME

• GxP Regulated Facilities, you: Will be responsible for ensuring compliance in all phases, such as design, purchase, construction, and qualification, establishing stable and ongoing robust processes Will ensure quality assurance oversight by following construction on site or by visiting our suppliers Will have the opportunity to work on the extensive expansion of our active pharmaceutical ingredient (API) production area, ensuring quality products for our many patients Will get to work with highly motivated and specialized colleagues as well as stakeholders Qualifications To succeed in this role, you have: A master's degree in Pharmacy, Engineering, or equivalent background Extensive experience in the pharmaceutical industry, preferably within project execution, design, and qualification 5 years of experience within quality assurance or production, and in depth knowledge related to good manufacturing practice (GMP) requirements for classified areas and HVAC systems Full English proficiency Strong communication skills On a personal level, you enjoy close teamwork, are a strong motivator for others, and can stay balanced when the waves get high.

You thrive in a multicultural environment, working across organizational borders and management levels.

Building structures comes naturally to you, and you enjoy simplifying wherever simplicity can benefit reaching the goals fast and in a sound and solid manner.

About the department API Expansion QA Projects is working to ensure involvement in the production facility investment projects in order to ensure compliance, timely approval, and the foundation for flawless operation of our new facilities.

The department collaborates with API production areas and internal and external stakeholders, both in DK and internationally. We highly value open communication and strong collaboration among our team. Social responsibility is a priority in the department; it must be fun and challenging to go to work. 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