QPd in Chemistry, Manufacturing, and Controls
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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 oral portfolio? If so, then apply today for a life-changing career! 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. You can also expect the following:
•Ensuring our products used in clinical trials are following the information provided to Health Authorities worldwide
•Identifying and contributing to strengthening our production facilities’ compliance level
•Acting as a consultant for production facilities
Office presence expected at minimum three days weekly. The department also supports the release from global Contract Manufacturing Organizations (CMO), offering the potential for growth and development in this area. Qualifications To succeed in this role, you have: •MSc in Pharmacy, Engineering, Biology, Chemistry or similar
•Solid experience with GMP and quality assurance, preferably from QP delegate position
•Hands-on experience with batch release/status assignment
•Well-developed understanding of quality
•Proficiency in English and Danish Experience with solid dosage forms (tablets) in a GMP environment and familiarity with SAP and PAS-X will be advantageous.
As a person, you're self-driven, responsible, and thriving in dynamic environments, prioritizing tasks adeptly. With strong teamwork and decision-making skills, you navigate pharmaceutical regulations seamlessly. 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. About the department You will become part of a department Chemistry, Manufacturing, and Controls Operational Planning Development (CMC OP Dev) QA & Analysis QA consisting of two teams where we currently are 25 dedicated colleagues. 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 products 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 do not wait for change. We drive it. We are 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 to manufacturing, marketing, and sales – we are all working to make a difference for millions of patients living with chronic diseases. Contact For further information, please contact Associate Manager, Rebecca Mia Larsen +45 3079 3687 Deadline 4 January 2024. Please, note applications will be reviewed on an ongoing basis and interviews will be scheduled as soon as suitable candidates are identified. 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.
•Ensuring our products used in clinical trials are following the information provided to Health Authorities worldwide
•Identifying and contributing to strengthening our production facilities’ compliance level
•Acting as a consultant for production facilities
Office presence expected at minimum three days weekly. The department also supports the release from global Contract Manufacturing Organizations (CMO), offering the potential for growth and development in this area. Qualifications To succeed in this role, you have: •MSc in Pharmacy, Engineering, Biology, Chemistry or similar
•Solid experience with GMP and quality assurance, preferably from QP delegate position
•Hands-on experience with batch release/status assignment
•Well-developed understanding of quality
•Proficiency in English and Danish Experience with solid dosage forms (tablets) in a GMP environment and familiarity with SAP and PAS-X will be advantageous.
As a person, you're self-driven, responsible, and thriving in dynamic environments, prioritizing tasks adeptly. With strong teamwork and decision-making skills, you navigate pharmaceutical regulations seamlessly. 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. About the department You will become part of a department Chemistry, Manufacturing, and Controls Operational Planning Development (CMC OP Dev) QA & Analysis QA consisting of two teams where we currently are 25 dedicated colleagues. 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 products 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 do not wait for change. We drive it. We are 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 to manufacturing, marketing, and sales – we are all working to make a difference for millions of patients living with chronic diseases. Contact For further information, please contact Associate Manager, Rebecca Mia Larsen +45 3079 3687 Deadline 4 January 2024. Please, note applications will be reviewed on an ongoing basis and interviews will be scheduled as soon as suitable candidates are identified. 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.
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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 24.8.2023, 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.
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