QA Specialist for Operational Readiness
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Gentofte
Are you thrilled about working with modern technology and like to push the boundaries of process performance and production technology? Does close international collaboration and networking across boundaries come natural for you? Then you might be the QA Specialist we are looking for to support the establishment of our new production facilities across the world, who will play a key role in the future of production in Novo Nordisk. Read more and apply now!
The position
As QA Specialist in Fill & Finish Expansions (FFEx) Quality you will set the direction for quality assurance operations when implementing new production lines in our global network. Your responsibilities will be to support and develop global operational readiness procedures ensuring a fast and sufficient ramp up of our new facilities worldwide.
Other responsibilities will include:
• ensuring compliance with internal and external quality requirements and regulatory requirements (GMP)
• being an integrated part of creating, developing, and challenging the overall programme plan to ensure efficient and transparent systems, structures, and processes
• setting the scene for the quality mindset in the programme
• aligning with other areas within FFEx to ensure clear interface and roles 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. Our department is new, hence changes in scope along the way may occur, allowing you to grow and develop within our organization.
This job is performed in an international environment and hence flexibility to travel is to some extent required.
Qualifications
We are looking for someone with a risk-based approach and the ability to balance compliance and product quality, a result-oriented person with a strong quality mindset.
To succeed in this role, you have:
• a Master’s degree in Engineering, Chemistry, Pharmacy or similar
• several years of experience in a QA role in the pharmaceutical industry
• GMP knowledge
• extensive experience with QA operations e.g., batch release, deviations handling
• full proficiency in English
We would also love for you to have a flair for IT and digitalisation.
As a person you are a team player, organized and have solid problem-solving capabilities, just as you show a can-do attitude and never lose your strategic focus. You can keep your spirit high even when under pressure and are a skilled communicator who can cooperate at any organizational level.
About the department
You will be joining FFEx Quality, an area anchored in Product Supply, Quality & IT (PSQIT), which globally employ approximately 20,000 of Novo Nordisk’s 50,000 employees.
It’s a newly established and growing area with the responsibility to design, plan and build all major FFEx projects across PSQIT to serve the needs of millions of patients, by rethinking our fill & finish facilities with the use of modern technology. We are setting the standards for the facilities of the future, which we will still be proud of 20 years from now.
Our department is responsible 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.
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 QA Director, Klaus Castagni Parasole Volhøj at +45 3075 6137.
Deadline
17 September 2023
We will conduct interviews on an ongoing basis, so do not hesitate to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation in your resume 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.
The position
As QA Specialist in Fill & Finish Expansions (FFEx) Quality you will set the direction for quality assurance operations when implementing new production lines in our global network. Your responsibilities will be to support and develop global operational readiness procedures ensuring a fast and sufficient ramp up of our new facilities worldwide.
Other responsibilities will include:
• ensuring compliance with internal and external quality requirements and regulatory requirements (GMP)
• being an integrated part of creating, developing, and challenging the overall programme plan to ensure efficient and transparent systems, structures, and processes
• setting the scene for the quality mindset in the programme
• aligning with other areas within FFEx to ensure clear interface and roles 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. Our department is new, hence changes in scope along the way may occur, allowing you to grow and develop within our organization.
This job is performed in an international environment and hence flexibility to travel is to some extent required.
Qualifications
We are looking for someone with a risk-based approach and the ability to balance compliance and product quality, a result-oriented person with a strong quality mindset.
To succeed in this role, you have:
• a Master’s degree in Engineering, Chemistry, Pharmacy or similar
• several years of experience in a QA role in the pharmaceutical industry
• GMP knowledge
• extensive experience with QA operations e.g., batch release, deviations handling
• full proficiency in English
We would also love for you to have a flair for IT and digitalisation.
As a person you are a team player, organized and have solid problem-solving capabilities, just as you show a can-do attitude and never lose your strategic focus. You can keep your spirit high even when under pressure and are a skilled communicator who can cooperate at any organizational level.
About the department
You will be joining FFEx Quality, an area anchored in Product Supply, Quality & IT (PSQIT), which globally employ approximately 20,000 of Novo Nordisk’s 50,000 employees.
It’s a newly established and growing area with the responsibility to design, plan and build all major FFEx projects across PSQIT to serve the needs of millions of patients, by rethinking our fill & finish facilities with the use of modern technology. We are setting the standards for the facilities of the future, which we will still be proud of 20 years from now.
Our department is responsible 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.
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 QA Director, Klaus Castagni Parasole Volhøj at +45 3075 6137.
Deadline
17 September 2023
We will conduct interviews on an ongoing basis, so do not hesitate to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation in your resume 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 21.8.2023, 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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