Senior QA Professional for Cleaning Validation

4 weeks ago


Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk AS Full time
Senior QA Professional for Cleaning Validation

Category: Quality

Location: Kalundborg, Region Zealand, DK

Novo Nordisk is establishing new, ground-breaking biotech facilities utilizing modern technology with fully automated operations and digitalized processes, for future oral and injectable production of Active Pharmaceutical Ingredients (API). Would you like to work in a dynamic, engaging, and international environment helping to ensure quality standards while building new technologies for the future? Then you might be the right candidate to join our department Product Supply API Expansions Quality Assurance (PS API Exp. QA) in Kalundborg - Denmark. Apply now for a life-changing career

The position
You will be part of a highly experienced team, whose focus is to ensure the right level of compliance in projects redesigning existing facilities and building brand new manufacturing plants for the future. As Senior Quality Assurance Professional for Cleaning Validation you will:

  • Work across the PS API organization with expansion projects for API production.
  • Be responsible for Cleaning QA routines related to system design, quality risk management, supplier management, equipment qualification and validation activities.
  • Find solutions that integrate quality and compliance within the organization.
  • Work in close collaboration with highly motivated and specialized colleagues and stakeholders.

You will work in expansion projects where you will be involved in all phases such as design, construction, qualification, and validation ensuring stable and robust processes.

Qualifications
To be a successful candidate, we expect you to have:

  • A B.Sc / M.Sc. in Pharmacy, Biology, Engineering, or equivalent background.
  • Extensive experience from the pharmaceutical industry (7+ years) preferably within project execution, supplier management, qualification, and validation routines.
  • Proven working experience with cleaning validation.
  • In-depth knowledge of QA routines, GMP requirements and production environments.
  • Full English proficiency and strong communication skills.

On a personal level, you enjoy close teamwork, are a strong motivator of 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
The PS API Expansions QA works to ensure involvement in investment projects aiming to establish compliant and timely approved facilities and setting the foundation for flawless operation of our new manufacturing plants. The department collaborates with API production areas, 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 to manufacturing, marketing and sales – we're all working to move the needle on patient care.

Contact
For further information, please contact Sr. Quality Assurance Project Manager: Álisson Granato on phone +45 3448 8398.

Deadline
23 February 2025. We will process applications as we receive them, so please do not hesitate to apply. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation to apply in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

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.

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