Senior QA Professional - Team Facility & Equipment
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Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? Are you skilled in navigating complex stakeholder landscapes and do you believe in working together is better than working on your own? Do you value good team spirit where everyone is each other's sparring partners and respect each other's opinions and knowledge?
If this sounds like you, then this might be the right job for you, read more and apply now!
The position As Senior QA Professional in Chemical, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA, you will be responsible for delivering best-in-class quality assurance of qualification of facilities and equipment used for GMP production of the API for clinical studies.
This includes: Cross functional collaboration with scientists in the API Pilot production and other QA colleagues To identify and contribute to strengthening our production facilities compliance level and act as a consultant for them Contribute to find solutions for ad hoc questions and challenges within GMP compliance To challenge and approve documentation regarding qualification of facilities and equipment as well as other supporting documents for the Pilot facilities To evaluate requirements and set the quality direction for the API Pilot production and projects
Qualifications We are looking for a candidate who has an understanding of quality, the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity, all combined with a natural urge to handle quality issues at the right level.
To succeed in this role, you: Hold an MSc in Pharmacy, Engineering, Biology, Chemistry or similar Have several years of experience within GMP and Quality Assurance Have gained said experience within the pharmaceutical industry Speak and write Danish and English fluently as we operate both in a national and an international environment
On a personal level, you can work with many tasks at the same time and will make decisions and follow up on quality related problems. 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. Furthermore, 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.
About the department CMC API QA is a department of 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 participate as QA for smaller or bigger investment projects to make our Pilot facilities more prepared for the future. We also have the responsibility of releasing API from contract manufacturers across the globe. We are divided into four teams, and you will be part of the Facility and Equipment team consisting of 9 QA professionals. The Team is responsible for assignments at the API pilot facilities assuring the quality of the facilities and the equipment.
In the department, we value teamwork, diversity and humour very high, and we will make sure you, as our new employee, feel welcome and integrated. You will receive an individual training plan made by your mentor.
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 and Scaling. We make a difference in the lives of people participating in clinical trials in A/S◀, by ensuring that the products they receive are safe, of the highest quality and produced in compliance with legislation.
Working at We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact For further information, please contact Manager Kristian Goldeman Ernstsen +or Senior QA Professional Anja Hjort +.
Deadline 18 August 2024
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 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.
If this sounds like you, then this might be the right job for you, read more and apply now!
The position As Senior QA Professional in Chemical, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA, you will be responsible for delivering best-in-class quality assurance of qualification of facilities and equipment used for GMP production of the API for clinical studies.
This includes:
Qualifications We are looking for a candidate who has an understanding of quality, the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity, all combined with a natural urge to handle quality issues at the right level.
To succeed in this role, you:
You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders. Furthermore, 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.
About the department CMC API QA is a department of 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 participate as QA for smaller or bigger investment projects to make our Pilot facilities more prepared for the future. We also have the responsibility of releasing API from contract manufacturers across the globe. We are divided into four teams, and you will be part of the Facility and Equipment team consisting of 9 QA professionals. The Team is responsible for assignments at the API pilot facilities assuring the quality of the facilities and the equipment.
In the department, we value teamwork, diversity and humour very high, and we will make sure you, as our new employee, feel welcome and integrated. You will receive an individual training plan made by your mentor.
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 and Scaling. We make a difference in the lives of people participating in clinical trials in A/S◀, by ensuring that the products they receive are safe, of the highest quality and produced in compliance with legislation.
Working at We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact For further information, please contact Manager Kristian Goldeman Ernstsen +or Senior QA Professional Anja Hjort +.
Deadline 18 August 2024
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 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 1.8.2024, 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.
- Øvrige
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