Advanced QA Professional for CMOs
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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 small molecules’ portfolio? If so, we have an exciting possibility waiting for you as QP delegate in Contract Manufacturing Organisations (CMC) Oral Product (OP) Development QA, read more and apply now! The position As Advanced QA Professional, 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. Novo Nordisk is expanding within small molecules and in this position, you will be part of building up our QMS and will primarily work with release from CMOs,
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 and this Advanced QA role will develop in a Qualified Person Delegate (QpD) position.
Office presence expected at minimum three days weekly. Qualifications 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. To succeed in this role, you: hold a MSc in Pharmacy, Engineering, Biology, Chemistry or similar; please note that your education should as a minimum support the demands and expectations to a “Qualified Person” from the Danish Medicines Agency (Lægemiddelstyrelsen)
have some years’ experience as a QA professional or in a production related role
must have gained said experience in the pharmaceutical industry
have experience with batch release/status assignment and CMOs
are fully proficient in English, both written and spoken
It will be seen as advantage if you have been working as a QP delegate and are knowledgeable within small molecules and/or Active Pharmaceutical Ingredients, Solid Dosage Oral Forms. 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 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 three teams where we currently are 40 dedicated colleagues. We are building up competencies within small molecules and therefore you will be a part of a newly established team. 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. 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. 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 Manager Claus Hatt Jensen +45 30 77 69 48 Deadline
1 September 2024 Interviews will be conducted continuously, so we encourage you to apply sooner rather than later. 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. 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.
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 and this Advanced QA role will develop in a Qualified Person Delegate (QpD) position.
Office presence expected at minimum three days weekly. Qualifications 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. To succeed in this role, you:
About the department You will become part of a department (CMC OP Dev QA & Analysis QA) consisting of three teams where we currently are 40 dedicated colleagues. We are building up competencies within small molecules and therefore you will be a part of a newly established team. 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. 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. 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 Manager Claus Hatt Jensen +45 30 77 69 48 Deadline
1 September 2024 Interviews will be conducted continuously, so we encourage you to apply sooner rather than later. 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. 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.
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 14.8.2024, 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.
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