Advanced QA Professional

7 days ago

Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Jobbeskrivelse
Placering
Bagsværd, Denmark

Jobkategori
Quality

Ansøg nu

Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? If so, this position as QA Professional in Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA could be a unique opportunity for you

The position
We are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. The successful candidate will support CMC API Development within the raw material and CMO shipping area. You will be responsible for ensuring compliance with regulatory requirements, quality standards, and company policies.

You will be a part of our development projects ensuring that raw materials for our products are used in clinical trials following the information provided to Health Authorities worldwide. Furthermore, you will - in close cooperation with your colleagues - identify and contribute to strengthening our production facilities' compliance level if needed and act as a consultant for stakeholders. You will contribute to finding solutions for ad hoc questions, deviations, and challenges within cGMP compliance.

Your responsibilities :

  • Responsible for delivering best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and drug product production for clinical trials.
  • Challenge and approve documents in connection with raw materials and CMO shipping.
  • Participate in regulatory inspections and audits and ensure compliance with cGMP and other regulatory requirements.
  • Responsible for securing quality agreements with external suppliers.

Qualifications
To succeed in this role, you have:

  • MSc in Pharmaceutical Sciences, Engineering, Biochemistry or similar.
  • At least 1 year of experience from the pharmaceutical industry within quality or production
  • Experience with GMP
  • Experience working with raw materials for API production
  • Proficiency in English
  • Proficiency in Danish is an advantage, but not a requirement

The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues with a necessary and sufficient mindset, make decisions and follow-up on quality related problems. You are a self-driven and independent person with a high sense of responsibility and initiative who can prioritize your many different tasks. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders – internally and externally.

About the department
CMC API QA is a department which employs 35 skilled and motivated colleagues in four teams, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials and the release of API for clinical trials. We also have the responsibility of releasing API from contract manufacturers across the globe.

In the department, we value teamwork, diversity and humor very high, and we will make sure you, as a new employee, feel welcome and integrated. Further, a thorough individual training plan will be made together with your mentor.

Contact
For further information, please contact Associate Manager Caroline Benedicte Kjærulff Mathiesen at or +45 34447617.

Deadline
11 September 2024. Note that applications will be reviewed on an ongoing basis and the position will be closed when we find the right candidate.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or 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.

#J-18808-Ljbffr

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