QA Professional in Validation for AP Expansions Quality
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Gentofte
About the job
Are you thrilled about working with modern technology and do you want to play a key role in the future of aseptic production in Novo Nordisk A/S?
Are you familiar with the different aspects of aseptic production processes and science and risk-based validation?
Then you might be the QA Professional we are looking for to support the establishment of our new aseptic production lines across the world.
The position
As QA Professional you will set the direction for quality assurance for one or more specific aseptic production (AP) processes, together with the work package owner responsible for the area.
The activities in AP Expansion Quality will include the entire value stream in a pharmaceutical filling facility ranging from the handling of incoming raw materials and components, wash & sterilisation, formulation, filling and to the final inspection of the products.
Your responsibilities will be starting at the early definition of requirements and right to the final qualifying tests using science and risk-based validation principles.
The job includes QA oversight of the suppliers and collaboration with local QA for the individual facilities.
Some international travel will be required.
Qualifications
You are positive, cooperative and solution oriented, and you work systematically, logically, and proactively.
You thrive in a dynamic environment where cooperation with many different stakeholders will be crucial to your success.
About us
AP Expansions Quality belongs in the newly established area AP Expansions. The new area is working to increase the aseptic production capacity across the Novo Nordisk network to ensure we continue to deliver high quality products for our patients, also in the future.
We want to rethink our way of aseptic production and build something we can be proud of – also in 20 years from now.
Our department has a global responsibility for quality assurance and compliance of the new facilities. We ensure a high level of quality and compliance with GMP in close cooperation with our stakeholders. We have an international collaboration with QA for the new facilities.
You will be a part of a team that works in a vibrant and positive working environment and values exchange of knowledge and experience. Networking and cooperation are key to our success.
Contact
For further information, please contact Associate Manager, Tine Møller Jørgensen at +45 3079 1621.
Deadline
Please submit your application no later than 7 January 2023.
Please note that interviews may start before the deadline, so feel free to submit your application as soon as possible.
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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Are you thrilled about working with modern technology and do you want to play a key role in the future of aseptic production in Novo Nordisk A/S?
Are you familiar with the different aspects of aseptic production processes and science and risk-based validation?
Then you might be the QA Professional we are looking for to support the establishment of our new aseptic production lines across the world.
The position
As QA Professional you will set the direction for quality assurance for one or more specific aseptic production (AP) processes, together with the work package owner responsible for the area.
The activities in AP Expansion Quality will include the entire value stream in a pharmaceutical filling facility ranging from the handling of incoming raw materials and components, wash & sterilisation, formulation, filling and to the final inspection of the products.
Your responsibilities will be starting at the early definition of requirements and right to the final qualifying tests using science and risk-based validation principles.
The job includes QA oversight of the suppliers and collaboration with local QA for the individual facilities.
Some international travel will be required.
Qualifications
- Master’s degree in pharmacy, chemical engineering or similar
- Minimum 3 years’ experience in aseptic production in the pharmaceutical industry
- Minimum 3 years’ experience with validation and qualification, preferably as a QA person
- Risk-based approach and the ability to balance compliance and product quality
- Strong quality mindset and result orientation
- Excellent skills in collaborating with stakeholders from different cultures and organisational levels
- Knowledge of IT and digitalisation
- Proficiency in Danish and English, speaking and writing
You are positive, cooperative and solution oriented, and you work systematically, logically, and proactively.
You thrive in a dynamic environment where cooperation with many different stakeholders will be crucial to your success.
About us
AP Expansions Quality belongs in the newly established area AP Expansions. The new area is working to increase the aseptic production capacity across the Novo Nordisk network to ensure we continue to deliver high quality products for our patients, also in the future.
We want to rethink our way of aseptic production and build something we can be proud of – also in 20 years from now.
Our department has a global responsibility for quality assurance and compliance of the new facilities. We ensure a high level of quality and compliance with GMP in close cooperation with our stakeholders. We have an international collaboration with QA for the new facilities.
You will be a part of a team that works in a vibrant and positive working environment and values exchange of knowledge and experience. Networking and cooperation are key to our success.
Contact
For further information, please contact Associate Manager, Tine Møller Jørgensen at +45 3079 1621.
Deadline
Please submit your application no later than 7 January 2023.
Please note that interviews may start before the deadline, so feel free to submit your application as soon as possible.
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 11.10.2022, 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
- Gentofte
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