QA Area specialist
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Gentofte
Are you looking for a leading position where you can apply your expertise setting strategic QA direction for implementation of new products as well as facility/process validation and driving change in BRD (Biotech and Rare Disease), to benefit patients with a wide range of chronic diseases? Does the idea of being involved in a new capacity expansion project where you can influence and impact future Active Pharmaceutical Ingredient (API) production sound of interest?
If so, read on to find out more about our new QA area specialist position based in Gentofte and apply!
The position
As QA area specialist, you will play a crucial role in the project. Your key task is to set direction and to ensure facilities and processes that support products of the highest quality to serve our patients. As a wide range of new products and technologies are entering BRD we seek additional competencies and knowledge of Process/Facility Validation to assist our department.
You will also help to ensure automated solutions integrate quality and compliance with good optimizations in production .
We believe that cLEAN, GMP (Good Manufacturing Practice) and digitalisation supports one another in the best way! This requires good cooperation and a solution-focused dialogue with both the production and your other QA colleagues.
Among your daily tasks, you will:
This project will give you the opportunity to be involved in a new, high-profile project where you will be part of shaping a new team of skilled QAs.
Qualifications
In your role you take responsibility, work independently, have a strong focus on collaboration and make decisions that balance quality demands, authority expectations, and business needs.
To succeed you:
You thrive in working cross functionally liaising and building relations with senior stakeholders.
Moreover, we are looking for an individual that is flexible and have a strong quality mind-set combined with the ability to increase simplicity in the processes. We appreciate a curious, innovative, and solution-oriented approach to overcome challenges.
About the department
Biotech Rare Diseases QA API Denmark is in Gentofte, Hillerød and Kalundborg. We are assuring the quality of the active ingredients, going into all our life-saving biotech products and we are approximately 50 committed colleagues.
Our products are manufactured through complex chemical and biotechnological processes requiring a high level of expertise, commitment, and engagement from all of us. The processes include cultivation, recovery and purification. We are, together with the production departments, producing at full speed in existing facilities, while building and ramping up new state of the art additions to keep up with demand and new Novo Nordisk products.
We bring value to patients by delivering the purest possible high-quality API made in compliance with GMP. We drive change by always looking for improvements within our processes, but also in the way we work together to make our products reach as many patients as possible.
In our department the teams have a high level of self-governance, and the working relations are informal. We value good humour and an open and honest culture. We have a high focus on a great work-life balance, with the flexibility to work from the office and remote.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That is why we make room for diverse career aspirations and always put people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it is a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 47,000 employees. Together, we go further. Together, we are life changing.
Contact
Do you want to know more about position please contact Jane Frederiksen on +45 3079 9796.
Application deadline
31 December 2022
Please note that applications will be reviewed continuously, and interviews will be planned as soon as suitable candidates have been 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.
Print job Send to e-mail
If so, read on to find out more about our new QA area specialist position based in Gentofte and apply!
The position
As QA area specialist, you will play a crucial role in the project. Your key task is to set direction and to ensure facilities and processes that support products of the highest quality to serve our patients. As a wide range of new products and technologies are entering BRD we seek additional competencies and knowledge of Process/Facility Validation to assist our department.
You will also help to ensure automated solutions integrate quality and compliance with good optimizations in production .
We believe that cLEAN, GMP (Good Manufacturing Practice) and digitalisation supports one another in the best way! This requires good cooperation and a solution-focused dialogue with both the production and your other QA colleagues.
Among your daily tasks, you will:
- Oversee all QA relevant activities related to the project
- Ensure compliance with regulatory and QMS (Quality Management System) requirements now and in the long run
- Review and approve of all documents related to the project
- Participate in meetings where QA direction is needed
- Participate in mandatory QMS meetings
This project will give you the opportunity to be involved in a new, high-profile project where you will be part of shaping a new team of skilled QAs.
Qualifications
In your role you take responsibility, work independently, have a strong focus on collaboration and make decisions that balance quality demands, authority expectations, and business needs.
To succeed you:
- Hold a master’s degree within a relevant field e.g. Engineering, Pharmacy, or similar
- Solid experience with more than 5 years of experience, preferably QA, with process/facility validation in the pharmaceutical industry
- Have extensive GMP experience
- Have good stakeholder management skills and table coordinating- and collaboration skills at all levels of the organization
- Are fluent in English both written and spoken
You thrive in working cross functionally liaising and building relations with senior stakeholders.
Moreover, we are looking for an individual that is flexible and have a strong quality mind-set combined with the ability to increase simplicity in the processes. We appreciate a curious, innovative, and solution-oriented approach to overcome challenges.
About the department
Biotech Rare Diseases QA API Denmark is in Gentofte, Hillerød and Kalundborg. We are assuring the quality of the active ingredients, going into all our life-saving biotech products and we are approximately 50 committed colleagues.
Our products are manufactured through complex chemical and biotechnological processes requiring a high level of expertise, commitment, and engagement from all of us. The processes include cultivation, recovery and purification. We are, together with the production departments, producing at full speed in existing facilities, while building and ramping up new state of the art additions to keep up with demand and new Novo Nordisk products.
We bring value to patients by delivering the purest possible high-quality API made in compliance with GMP. We drive change by always looking for improvements within our processes, but also in the way we work together to make our products reach as many patients as possible.
In our department the teams have a high level of self-governance, and the working relations are informal. We value good humour and an open and honest culture. We have a high focus on a great work-life balance, with the flexibility to work from the office and remote.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That is why we make room for diverse career aspirations and always put people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it is a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 47,000 employees. Together, we go further. Together, we are life changing.
Contact
Do you want to know more about position please contact Jane Frederiksen on +45 3079 9796.
Application deadline
31 December 2022
Please note that applications will be reviewed continuously, and interviews will be planned as soon as suitable candidates have been 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.
Print job Send to e-mail
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Gentofte.
Jobbet er oprettet på vores service den 7.12.2022, 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
- Gentofte
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