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QA Specialist

2 months ago

Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

About the Role

We are seeking a highly skilled and motivated QA Specialist to join our team at Novo Nordisk A/S. As a QA Specialist, you will play a critical role in ensuring the quality of our products and processes.

Key Responsibilities

  • Safeguard that analytical results are released in full compliance with current practice and guidelines from authorities.
  • Review and approve various types of GMP documentation related to analytical methods and laboratory equipment.
  • Oversee analyses performed such as HPLC, Bio- and Immunoassay, and general pharmacopeia methods including microbiology.
  • Support the development and validation of analytical and microbial methods for new products entering our product pipeline, both in-house and at our Contract Manufacturing Organizations.
  • Support and oversee quality activities at our QC laboratories in Gentofte, Hillerød, and Kalundborg.

Requirements

  • At least 1 year of experience in the pharmaceutical industry, from e.g. QA, QC, or production.
  • A master's degree within pharmacy, chemistry, microbiology, engineering, or similar.
  • IT knowledge and competencies are considered an advantage.
  • Fluency in both English and Danish.

About the Department

You will join a team in a highly dynamic, newly established department in Aseptic Manufacturing QA with many interfaces and stakeholders around the organization. The department consists of four teams who are supporting and overseeing QC laboratories and analytical methods, support functions to production and product life cycle, support projects and IT and are highly involved in the core of quality processes and authority inspections.

Working at Novo Nordisk

At Novo Nordisk, we always strive for excellence and continuously develop our expertise to stay ahead - both as a company and as individuals. We believe that innovation and creativity thrive in a healthy and engaging working environment. Therefore, we give you the opportunity to bring your personal ambition and passion to work to improve the quality of life of the patients.

Contact

For more information, please contact QA Manager Karoline Hauberg Rasmussen.