Senior QA professional for Qualification /Validation
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Bagsværd
Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? Would you like to use your solid QA and validation experience in a project context?
Then we can offer you a unique position with a lot of impact in a dynamic environment and an opportunity to really develop your skills professionally and personally, read more below and apply!
The position
Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA is looking for a new colleague to be part of an optimization project - Warp Speed - that is already running at full speed. The CMC API pilot facilities are expanding their production capacity for clinical trials, and we are looking for a new QA colleague to work with our 3 other QA colleagues allocated for this project.
In this role, you will be responsible for:
• delivering best-in-class quality for qualification of facilities and equipment according to Science Risk based Validation principals
• communicating cross functionally with scientists in the project and your QA colleagues
• challenging and approving documentation regarding qualification of facilities and equipment
• participating in workshops prior to setting the criteria for the new facilities and equipment´s
• evaluating requirements and setting the quality direction for the projects
When Warp Speed Project ends (ultimo 2024), you will be part of the daily operations in the Facility & Equipment team in CMC API QA. You will - in close cooperation with your colleagues - identify and contribute to strengthening our production facilities compliance level and contribute to find solutions for ad hoc questions and challenges within GMP compliance, and you will challenge and approve documentation regarding qualification of facilities and equipment as well as other supporting documents for the Pilot facilities.
Qualifications To succeed in this role, you:
• hold an MSc in Pharmacy, Engineering, Biology, Chemistry or similar
• have minimum 5 years of experience within the pharmaceutical industry, in either QA or production
• have extensive GMP knowledge
• understand the important aspects of regulations, requirements and guidelines for pharmaceutical development
• are fluent in English and know, or are open to learn, Danish On a personal level, you can work with several tasks at the same time and can 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 Finally, you thrive in a dynamic environment, where teamwork is on the top of the agenda and you like working with many different stakeholders.
About the department
CMC API QA is a department which employ 25 skilled and motivated colleagues divided in two teams both based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities & equipment as well as the release of raw materials, cell banks and 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 are continuously improving the quality of work, and we optimise 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. Our department values teamwork, diversity, and humour and we will make sure that you, as our new employee, feel welcome and included. A thorough individual training plan will be made for you together with your mentor. 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 Associate Manager Charlotte Hellesøe Ørtoft +45 3075 1742 or Validation Specialist Anne Rønholt +45 3079 0638
Deadline
24 September 2023
Applications will be reviewed ongoing. Interviews are held continuously, and employment can thus potentially take place before the deadline.
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.
Then we can offer you a unique position with a lot of impact in a dynamic environment and an opportunity to really develop your skills professionally and personally, read more below and apply!
The position
Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA is looking for a new colleague to be part of an optimization project - Warp Speed - that is already running at full speed. The CMC API pilot facilities are expanding their production capacity for clinical trials, and we are looking for a new QA colleague to work with our 3 other QA colleagues allocated for this project.
In this role, you will be responsible for:
• delivering best-in-class quality for qualification of facilities and equipment according to Science Risk based Validation principals
• communicating cross functionally with scientists in the project and your QA colleagues
• challenging and approving documentation regarding qualification of facilities and equipment
• participating in workshops prior to setting the criteria for the new facilities and equipment´s
• evaluating requirements and setting the quality direction for the projects
When Warp Speed Project ends (ultimo 2024), you will be part of the daily operations in the Facility & Equipment team in CMC API QA. You will - in close cooperation with your colleagues - identify and contribute to strengthening our production facilities compliance level and contribute to find solutions for ad hoc questions and challenges within GMP compliance, and you will challenge and approve documentation regarding qualification of facilities and equipment as well as other supporting documents for the Pilot facilities.
Qualifications To succeed in this role, you:
• hold an MSc in Pharmacy, Engineering, Biology, Chemistry or similar
• have minimum 5 years of experience within the pharmaceutical industry, in either QA or production
• have extensive GMP knowledge
• understand the important aspects of regulations, requirements and guidelines for pharmaceutical development
• are fluent in English and know, or are open to learn, Danish On a personal level, you can work with several tasks at the same time and can 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 Finally, you thrive in a dynamic environment, where teamwork is on the top of the agenda and you like working with many different stakeholders.
About the department
CMC API QA is a department which employ 25 skilled and motivated colleagues divided in two teams both based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities & equipment as well as the release of raw materials, cell banks and 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 are continuously improving the quality of work, and we optimise 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. Our department values teamwork, diversity, and humour and we will make sure that you, as our new employee, feel welcome and included. A thorough individual training plan will be made for you together with your mentor. 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 Associate Manager Charlotte Hellesøe Ørtoft +45 3075 1742 or Validation Specialist Anne Rønholt +45 3079 0638
Deadline
24 September 2023
Applications will be reviewed ongoing. Interviews are held continuously, and employment can thus potentially take place before the deadline.
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 Bagsværd.
Jobbet er oprettet på vores service den 15.3.2023, 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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