- Denmark - Måløv
Are you looking for new challenges within QA? Do you want to be part of the team establishing a new tablet and packaging facility and do you want to make a difference? We establishing a new oral drug product facility and QA function, and therefore we are looking for a dedicated, professional and enthusiastic new colleague.
About the department
In Oral DP Launch Plant QA we have the responsibility for quality assurance of the establishment of the new tablet and packaging facility located in Måløv. Furthermore we’re responsible for quality assurance of the quality management system in the new organisation as well as establishing the new QA department.
In close cooperation with your colleagues in QA, you act as a QA for project team establishing the new facility. You contribute to finding solutions for ad hoc questions and challenges within compliance of GMP facilities. The job is related to qualification/validation of equipment and facilities for oral drug product manufacture and packaging. 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 requests, non-conformities, SOP’s, environmental monitoring and utilities.
Our continuing high level of audit and inspection readiness is on top on your agenda.
This means that in QA we work with QA oversight where you proactive, together with your colleagues, will identify areas where our compliance can be strengthened. 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.
Ideally, you have a master in Pharmacy, Chemical Eng. or corresponding qualifications and at least 5 years of experience within the pharmaceutical industry. You have thorough knowledge within some of the following areas: GMP, validation/qualification, equipment used in tablet or aseptic production.
You enjoy working in a dynamic environment, where teamwork is at the top of the agenda. 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 Peter Søtofte Elten +45 3079 8453.
31 October 2015.