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Qualification QA for Pilot Tablet Facilities

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Novo Nordisk A/S

Ballerup, 1 stilling

- Quality
- Denmark - Måløv

Are you looking for new challenges within QA? Is development of tablets for clinical trials your favourite discipline and do you want to make a difference? We are building a new brand new oral drug product facility, so if you want to be part of something unique then this is your chance!

About the department
In CMC Oral Protein Formulation QA we have the responsibility for quality assurance of oral formulations and release of tablets for clinical trials. We have the QA responsibility of the oral formulation development department, the oral pilot production, and building of a new production facility.

The job
In close cooperation with your 15 QA colleagues, you will be the QA for our pilot plant. You contribute to finding solutions for ad hoc questions and challenges within compliance of the entire facility.

The job is specifically related to qualification/validation of equipment in the pilot facilities. You will assure that the documentation for implementation and maintenance of equipment is compliant with internal and external requirements. Furthermore, you will approve facility related documentation needed for the operation of the plant such as change request, non-conformities, SOP’s, environmental monitoring and utilities.

Our continuing high level of audit and inspection readiness is on top on our agenda. This means that we work with QA oversight where you proactive, together with your colleagues, will identify areas where our stakeholders’ compliance can be strengthened.

You have a risk based approach to the development process and product, and you contribute to finding the right balance between patient safety, compliance to requirements and effective business conduct.

Ideally, you have a master in Pharmacy, Chemical Eng. or corresponding qualifications and at least 2 years of experience within the pharmaceutical industry. You have knowledge within some of the following areas: GMP, validation/qualification or equipment used in tablet production.

You enjoy working in a dynamic environment, where teamwork is part of you mind-set. Also, you are quite adaptable and challenge our way of doing things, so that we will get even better. You focus on results and quality – and contribute to the right level of compliance.

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

For further information please contact Janne Lavritsen +45 3075 7333.

8 November 2015.