QA Academic, Corporate Product Quality Assurance Biologics

Are you curious and passionate about quality assurance work in the pharmaceutical industry? Do you possess an analytical and data-oriented mindset? Are you motivated by problem-solving and finding new solutions to the way we work with skilled colleagues? Then you could be just the person we are looking for!  

Corporate Product Quality Assurance Biologics (CPQA Biologics) is searching for a QA Academic who is ready to be part of well-functioning and engaged team.

Your new role

As a QA Academic in CPQA Biologics you will be offered a job in a growing department in Lundbeck, having close collaboration with internal and external stakeholders involved in production of biologics for H. Lundbeck A/S.

Your will report to the Director of CPQA Biologics and be part of an informal team of highly competent and motivated colleagues.

Taks
Your primary area of responsibility will be QA deliverables related to Contract Manufacturing Organization activities, including:

• Review and release of Bulk Drug Substance, Bulk Drug Product and Finished Goods.

• Review and release of certificates.

• Case handling of deviations and change requests.

• Optimization of procedures for the way we work.

• Involvement in cross-functional projects.

• Support to affiliates and stakeholders

Through your training you will develop cross-organizational competencies and gain knowledge of relevant international and national legislation for production and release of biological medicinal products. You will be given ample opportunity to influence and optimize the way we work; operational excellence is a part of our culture.

Your future team

The team consists of 4 employees (3 academics and 1 technician) who are responsible for all commercial QA-related activities in connection with oversight of Lundbeck’s biological production at our CMO’s, as well as review and release to market for these products.

Your primary place of work will be at Lundbeck’s headquarter site in Valby. Aside from the daily work with releasing biological products to market we also participate in cross-organizational projects on commercial and late-stage biological candidates.

What you bring to the team

Our preferred candidate possesses the following personnel and professional qualifications:

• You have an M.Sc. in natural sciences preferably pharmaceutical science.

• Knowledge of GMP and one-year practical experience is a plus.

• Competencies to act as a QP-delegate is likewise a plus.

• Good collaborative skills and a pragmatic approach to problem solving.

• A cooperative attitude.

• Fluid in Danish and English, both written and verbally.

Our promise to you

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.