QA Professional in Validation for AP Expansions Quality – Novo Nordisk A/S – Gentofte

About the job Are you thrilled about working with modern technology, do you like to push the boundaries of production technology and do you want to play a key role in the future of aseptic production in Novo Nordisk A/S? Are you familiar with the different aspects of aseptic production processes and science and risk-based validation? Then you might be the QA Professional we are looking for to support the establishment of our new aseptic production lines across the world. The position As QA Professional you will set the direction for quality assurance for one or more specific aseptic production (AP) processes, together with the work package owner responsible for the area. The activities in AP Expansion Quality will include the entire value stream in a pharmaceutical filling facility ranging from the handling of incoming raw materials and components, wash & sterilisation, formulation, filling and to the final inspection of the products including IT/OT. Your responsibilities will be starting at the early definition of requirements and right to the final qualifying tests using science and risk-based validation principles. The job includes QA oversight of the suppliers and collaboration with local QA for the individual facilities. Some international travel will be required. Qualifications Master’s degree in pharmacy, chemical engineering or similar Minimum 3 years’ experience in aseptic production in the pharmaceutical industry Minimum 3 years’ experience with validation and qualification, preferably as a QA person Risk-based approach and the ability to balance compliance and product quality Strong quality mindset and result orientation Excellent skills in collaborating with stakeholders from different cultures and organisational levels Knowledge of IT and digitalisation Proficiency in Danish and English, speaking and writing You are a self-driven and self-motivated person with initiative and a high sense of responsibility. You thrive in a dynamic environment where cooperation with many different stakeholders and in the team will be crucial to your success. About the department AP Expansion Quality is a department in the newly established SVP area named AP Expansions. AP Expansions is working to increase the aseptic production capacity across the Novo Nordisk network to ensure we continue to deliver high quality products for our patients, also in the future. We want to rethink our way of aseptic production and build something we can be proud of – also in 20 years from now. Our department is responsible for quality assurance and regulatory approval of the new facilities. We ensure a high level of quality and compliance with GMP in close cooperation with our stakeholders. You will be a part of a team that works in a vibrant and positive working environment and values exchange of knowledge and experience. Networking and cooperation are key to our success.

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