Experienced Quality Specialist
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Gentofte
Are you thrilled about working with modern project execution and validation, do you like to challenge, improve, and set new standards, and do you want to play a key role in the future of aseptic production in Novo Nordisk A/S? Does close international collaboration and networking across boundaries come natural for you and do you have experience with science and risk-based validation?
Then you might be the Quality Specialist we are looking for Global Project Execution based in Gentofte! Read on to find out more…
The position
As Quality Specialist in Aseptic Production (AP) Expansions Program Quality, you will work at a strategic level, setting the direction for quality assurance using Science and Risk based Validation (SRV) principles when implementing new AP lines across the world!
Whilst collaborating with the Project Director and senior stakeholders locally and globally, your responsibilities will range from the early definition of requirements to the final qualification, and you will cooperate with local team and project sites creating a standardised effective SRV execution setup. You will also be an integrated part of creating, developing, and challenging the overall programme plan to ensure efficient and transparent systems, structures, and processes.
Other activities include: Ensuring compliance with internal and external quality requirements and regulatory requirements (GMP). Setting the scene for the quality mindset in the programme. Aligning with other areas within AP Expansions to ensure clear interface and roles. Cooperation across NN to identify best practice SRV solutions. Setting direction for the validation strategy in AP Expansions and for the individual work packages.
As this position has a global scope, you will have the opportunity for some international travel to our global sites.
Qualifications A degree in Engineering, Chemistry, Pharmacy or similar. 8+ years’ experience in aseptic production/ GMP in the pharmaceutical industry. Collaborated at a strategic level, setting direction, and executing on processes. Strong QA experience/ mindset which includes validation/ qualification and SRV. Knowledge/ interest in IT and digitalisation.
As a person you enjoy a challenge and able to work in partnership with the department, inspiring others with your visions and work collaboratively globally and cross functionally to problem solve and bring together knowledge to improve and create quality and processes. Your great communication skills give you a natural flair for clear communication and being able to make things simplistic when interacting with stakeholders at all levels. For this position, you are required to be fluent in spoken and written English.
About the department AP Expansions Program Quality is a department in the newly established SVP area named AP Expansions. AP Expansions 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 is responsible for establishing standardised SRV execution standards to be applied across the project sites for all qualification phases. We ensure a high level of quality and compliance with GMP in close cooperation with our stakeholders. 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.
Working at Novo Nordisk
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 Kenneth Petersen (Project Director, Quality Planning) on: +45 3075 4777 or email [email protected]
Deadline
30 April 2023. Please note, applications will be reviewed, and interviews will be conducted on an ongoing basis. 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 you might be the Quality Specialist we are looking for Global Project Execution based in Gentofte! Read on to find out more…
The position
As Quality Specialist in Aseptic Production (AP) Expansions Program Quality, you will work at a strategic level, setting the direction for quality assurance using Science and Risk based Validation (SRV) principles when implementing new AP lines across the world!
Whilst collaborating with the Project Director and senior stakeholders locally and globally, your responsibilities will range from the early definition of requirements to the final qualification, and you will cooperate with local team and project sites creating a standardised effective SRV execution setup. You will also be an integrated part of creating, developing, and challenging the overall programme plan to ensure efficient and transparent systems, structures, and processes.
Other activities include:
Qualifications
About the department AP Expansions Program Quality is a department in the newly established SVP area named AP Expansions. AP Expansions 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 is responsible for establishing standardised SRV execution standards to be applied across the project sites for all qualification phases. We ensure a high level of quality and compliance with GMP in close cooperation with our stakeholders. 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.
Working at Novo Nordisk
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 Kenneth Petersen (Project Director, Quality Planning) on: +45 3075 4777 or email [email protected]
Deadline
30 April 2023. Please note, applications will be reviewed, and interviews will be conducted on an ongoing basis. 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 Gentofte.
Jobbet er oprettet på vores service den 17.3.2023, 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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