QP delegate in CMC QA
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Måløv
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 and be part of an exciting growth journey within our oral portfolio? If so, we have an exciting possibility waiting for you as QP delegate in CMC OP Dev (Oral Product Development) QA! The position
As a QP delegate, you will be responsible for delivering best-in-class quality assurance of our new manufacturing processes and drug product for clinical trials. In your daily work you will challenge and approve documents in connection with development, manufacture, stability, and status assignment of clinical batches. In addition, you will be a part of our development projects ensuring our products used in clinical trials are 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 and act as a consultant for them. The department also supports release from international Contract Manufacturing Organisations (CMO), and it is possible to be trained in this as well. The position is based in Måløv, scored internally as a level 6 position. Office presence expected at minimum three days weekly.
Qualifications You hold a MSc in Pharmacy, Engineering, Biology, Chemistry or similar. (Your education should as a minimum support the demands and expectations to a “Qualified Person” from the Danish Medicines Agency (Lægemiddelstyrelsen). ) You have 3+ years of experience with GMP and quality assurance (preferably within batch release/status assignment.) You have proficiency in English and Danish language It is an advantage if you have been working as a Qualified Person for some years and has worked with solid dosage forms (tablets) in a GMP environment. 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 at the right level, make decisions and follow-up on quality related problems. You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity. You are a self-driven and independent person with a high sense of responsibility and initiative who can prioritise your many different tasks. You thrive in a dynamic environment, where teamwork is on top of the agenda, and you like working with many different stakeholders – internally and externally. About the department You will become part of a department (CMC OP Dev QA & Analysis QA) consisting of two teams where we currently are 25 dedicated colleagues. You will be part of the CMC OP Dev QA team, reporting directly to the QA director. You will be part of a strong culture, where we strive for high psychological safety, give regular feedback, and understand that the most important thing we have is our people. Our main purpose is to safeguard patient safety and ensure product quality and compliance in the CMC area, and ultimately release drug candidates for clinical trials. As part of Novo Nordisk Quality, we support the business and strive for simplicity every single day, to ensure Novo Nordisk’s critical delivery of medicine to patients. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact For further information, please contact QA Director Casper Yding +45 3079 7015 Deadline 18th of June Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible. 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. 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.
As a QP delegate, you will be responsible for delivering best-in-class quality assurance of our new manufacturing processes and drug product for clinical trials. In your daily work you will challenge and approve documents in connection with development, manufacture, stability, and status assignment of clinical batches. In addition, you will be a part of our development projects ensuring our products used in clinical trials are 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 and act as a consultant for them. The department also supports release from international Contract Manufacturing Organisations (CMO), and it is possible to be trained in this as well. The position is based in Måløv, scored internally as a level 6 position. Office presence expected at minimum three days weekly.
Qualifications
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 12.5.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
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