QP delegate in CMC API QA
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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? If so, then this position can be a unique possibility for you.
The position
As a QP delegate, you will be responsible for delivering best-in-class quality assurance
of our API for clinical trials. In your daily work you will challenge and approve documents in connection with development-, manufacturing- and stability activities, and you will status assign APIs. 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. You will contribute to finding solutions for ad hoc questions and challenges within cGMP compliance. In our department, we are continuously improving the quality of work, and we are constantly optimising our methods and processes to increase simplicity across CMC QA and CMC Development. We make a difference in the lives of people participating in clinical trials in Novo Nordisk A/S, by ensuring that the products they receive are safe, of the highest quality, and produced in compliance with legislation. Qualifications You hold a master’s degree in pharmacy, engineering or similar. Your education should as a minimum support the demands and expectations to a “Qualified Person” from the Danish Medicines Agency (Lægemiddelstyrelsen). Preferably, you have 3+ years of experience with GMP and quality assurance and have experience with batch release/status assignment combined with understanding of how the pharmaceutical industry works. 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. 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 with a necessary and sufficient mindset. You are a self-driven and independent person with a high sense of responsibility and initiative.
You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders. Further, it is key that you value being part of a top-performing team, were we use regular feedback and challenge each other to become even better. We operate both in a national and an international environment, therefore, you must speak and write Danish and English fluently. About the department CMC API QA is a department which employ 24 skilled and motivated colleagues, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials as well as the release of API for clinical trials. We also have the responsibility of releasing API from contract manufacturers across the globe. We are divided into two teams, and you will be part of the Product-Materials team consisting of both QP delegates, professionals and technicians. In the department, we value teamwork, diversity and humour very high, and we will make sure you, as a new employee, feel welcome and integrated. Further, a thorough individual training plan will be made together with your mentor. Contact For further information, please contact Department Manager Rikke Wissing Jensen at +45 30751566 or Teamleader Michael Ellebæk Kongsgaard at +45 34482627. Deadline 31/01/2023
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.
The position
As a QP delegate, you will be responsible for delivering best-in-class quality assurance
of our API for clinical trials. In your daily work you will challenge and approve documents in connection with development-, manufacturing- and stability activities, and you will status assign APIs. 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. You will contribute to finding solutions for ad hoc questions and challenges within cGMP compliance. In our department, we are continuously improving the quality of work, and we are constantly optimising our methods and processes to increase simplicity across CMC QA and CMC Development. We make a difference in the lives of people participating in clinical trials in Novo Nordisk A/S, by ensuring that the products they receive are safe, of the highest quality, and produced in compliance with legislation. Qualifications You hold a master’s degree in pharmacy, engineering or similar. Your education should as a minimum support the demands and expectations to a “Qualified Person” from the Danish Medicines Agency (Lægemiddelstyrelsen). Preferably, you have 3+ years of experience with GMP and quality assurance and have experience with batch release/status assignment combined with understanding of how the pharmaceutical industry works. 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. 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 with a necessary and sufficient mindset. You are a self-driven and independent person with a high sense of responsibility and initiative.
You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders. Further, it is key that you value being part of a top-performing team, were we use regular feedback and challenge each other to become even better. We operate both in a national and an international environment, therefore, you must speak and write Danish and English fluently. About the department CMC API QA is a department which employ 24 skilled and motivated colleagues, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials as well as the release of API for clinical trials. We also have the responsibility of releasing API from contract manufacturers across the globe. We are divided into two teams, and you will be part of the Product-Materials team consisting of both QP delegates, professionals and technicians. In the department, we value teamwork, diversity and humour very high, and we will make sure you, as a new employee, feel welcome and integrated. Further, a thorough individual training plan will be made together with your mentor. Contact For further information, please contact Department Manager Rikke Wissing Jensen at +45 30751566 or Teamleader Michael Ellebæk Kongsgaard at +45 34482627. Deadline 31/01/2023
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 Bagsværd.
Jobbet er oprettet på vores service den 25.10.2022, 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
- Bagsværd
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