Qualified Person Delegate for new tablet product

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Måløv

  • Quality
  • Måløv

Do you want to be part of the team bringing Rybelsus to patients all over the world? Novo Nordisk has built a new factory in Måløv which will be part of setting new standards for diabetes treatment. To succeed with this ambition, we need people with high level of team spirit, having high engagement and who thrives in a constant changing environment.

About the department

In 2004 an ambitious and path-breaking journey began for us to become the first medical company delivering GLP-1-based tablets to the market. This year we delivered Rybelsus tablets to the first patients and going foward millions of patients with type-2 diabetes will have an oral alternative to injectable preparation. This is a result of competent, innovative and engaged employees’ efforts across the organization, who are proud to use their dedication to make totally new standards within the diabetes treatment. Join us at our journey – a possibility to make a personal and professional development.

Oral Finished Products QA is a department which employ approximately 25 skilled and motivated colleagues. We work with assuring quality and compliance of the facilities, the equipment, QC lab and the quality management system as well the release of tablets for the market.

In OFP QA we make a huge effort for you as a new employee to be off to a good start. During the first few days you will spend some time with other new employees in the OFP area, where you will get an exciting introduction to OFP. The manager will welcome you, and a colleague will act as a mentor and go through your individual training plan. We know how important it is, and we are looking forward to meeting you.

The job

You will act as QP delegate and you will have the overview of the processes within development and production of oral medicinal products. You will approve quality documentation from manufacturing development which includes: Technology transfer documents, specifications, stability documentation, manufacturing batch records, cleaning records, risk assessments, deviations, change requests and other relevant documents as well as executing the QP release and perform batch confirmation.

In close cooperation with your colleagues in QA, you act as a QA for the Oral Finished Product area. You contribute to finding solutions for ad hoc questions and challenges within cGMP compliance. Your main focus will be assuring that the documentation related to the manufacture of drug product for the market is compliant with internal and external requirements.

Furthermore, you will assist your colleagues in approving the documentation needed for the operation of the laboratory and the factory such as change requests, non-conformities and SOP’s.

Our continuing high level of audit and inspection readiness is on top on your agenda. This means that we work with QA oversight where you proactive, together with your colleagues, will identify areas where our compliance can be strengthened. Moreover, you have a risk based approach to the manufacturing process and product, and you contribute to find the right balance between patient safety, compliance to requirements and effective business conduct.

Qualifications

You hold an academic degree as pharmacist and have at least 3 years of experience from a pharmaceutical or medical device organisation, where you have gained a solid and up-to-date knowledge of quality and GMP requirements. You must be fluent in both written and spoken Danish and English.

The ideal candidate has thorough knowledge within manufacturing and/or quality assurance of oral solid dosage forms.

You enjoy working in a dynamic environment where teamwork is on top of the agenda. Also, you are quite adaptable and challenge our way of doing things, so we simplify and improve our processes. You focus on results and quality – and contribute to the right level of compliance.

Join us at our journey – a possibility for you to make a personal and professional development.

Working at Novo Nordisk

At Novo Nordisk, we have been changing diabetes since 1923. If you are ready to strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us to make the most of your talent.

Contact

For further information, please contact Sine Godiksen +45 3075 1426.

Deadline

22 March 2020.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


Information og data

Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".

Arbejdsstedet er beliggende i Måløv.

Jobbet er oprettet på vores service den 6.2.2020, men kan have været deaktiveret og genaktiveret igen.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Produktspecialist
  • Måløv
  • Søndag den 22. marts 2020
Rapportér

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