QA Project Specialist
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Søborg
Are you looking for a place to feed your enthusiasm for quality? Are you excited about playing a crucial role in ensuring quality processes in Novo Nordisk’s global network of Contract Manufacturer Organisations (CMOs)? Then you can look forward to a leading role where your efforts can make a positive and direct difference every day, apply now to become our new QA Project Specialist!
The position
In this position you will be the QA in project transfers from Novo Nordisk to CMOs. You will participate in various projects within Drug Products and Finished Products, working with both internal and external business partners and with a high level of complexity and independent decision making in your daily tasks. Main responsibilities include:
• Quality responsibility for the technical transfer to the CMOs
• Taking lead in ensuring the CMO Quality Management System (QMS) is compliant to fulfil relevant GMP requirements
• Negotiation and implementation of quality agreements, approving process validation strategy and related documents
• Setting up the QA processes for commercial manufacturing.
• Participating in qualification audits performed at the CMO and ensure sufficient follow up on CAPAs Moreover, you will manage quality issues during the technical transfer such as: Process validation documentation, deviations, out of specifications, change controls, action plan and follow up, evaluate production documentation. Expected travel is around 20 days a year as the CMOs are located outside Denmark primarily Europe and US. You will have great professional and personal development opportunities in a well-functioning department. We can offer you a working environment with a high level of team spirit as well as highly skilled, ambitious, and engaged colleagues.
Qualifications To succeed in this role, you: • hold an academic degree as Pharmacist, Engineer or similar
• have a minumum of 5 years' experience from the pharmaceutical industry either from production or QA
• have a solid and up-to-date knowledge of quality and GMP requirements and have the ability to take decisions on quality representing Novo Nordisk
• are proficient in English, and preferably in Danish as well
It is an advantage if you have extensive knowledge within Drug Products and Finished Products. On a personal level, you have a natural ability to take lead and work as a team player, proactively contributing to the team’s tasks and activities. You have the ability to work in an international set-up with external stakeholders with different interests and agendas, using your great communication and collaboration skills. We would enjoy welcoming a straightforward person with a good sense of humour to our department. Finally, you meet own deadlines and know how to prioritise between different tasks in an everchanging environment.
About the department
Global Contract Manufacturing (GCM) QA is responsible for quality assurance and quality support to outsourced production activities worldwide. GCM QA is a dynamic department consisting of 70 competent people divided into 8 teams with focus on either operations or projects. You will be a strong player in the project team. The department is characterised by a high level of professionalism, flexibility, and cooperation. The primary role of our department is to deliver QA support and set direction for our global CMOs.
We focus on good social relations and prioritise to make room for fun at work. We have weekly quizzes, and we strive to have daily workout sessions to ensure on-going well-being in the team.
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 Lene Cletus Petersen on +45 3079 0412. Deadline
13th December 2023 You do not need to attach a cover letter to your application, but please include a few sentences about your motivation 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.
The position
In this position you will be the QA in project transfers from Novo Nordisk to CMOs. You will participate in various projects within Drug Products and Finished Products, working with both internal and external business partners and with a high level of complexity and independent decision making in your daily tasks. Main responsibilities include:
• Quality responsibility for the technical transfer to the CMOs
• Taking lead in ensuring the CMO Quality Management System (QMS) is compliant to fulfil relevant GMP requirements
• Negotiation and implementation of quality agreements, approving process validation strategy and related documents
• Setting up the QA processes for commercial manufacturing.
• Participating in qualification audits performed at the CMO and ensure sufficient follow up on CAPAs Moreover, you will manage quality issues during the technical transfer such as: Process validation documentation, deviations, out of specifications, change controls, action plan and follow up, evaluate production documentation. Expected travel is around 20 days a year as the CMOs are located outside Denmark primarily Europe and US. You will have great professional and personal development opportunities in a well-functioning department. We can offer you a working environment with a high level of team spirit as well as highly skilled, ambitious, and engaged colleagues.
Qualifications To succeed in this role, you: • hold an academic degree as Pharmacist, Engineer or similar
• have a minumum of 5 years' experience from the pharmaceutical industry either from production or QA
• have a solid and up-to-date knowledge of quality and GMP requirements and have the ability to take decisions on quality representing Novo Nordisk
• are proficient in English, and preferably in Danish as well
It is an advantage if you have extensive knowledge within Drug Products and Finished Products. On a personal level, you have a natural ability to take lead and work as a team player, proactively contributing to the team’s tasks and activities. You have the ability to work in an international set-up with external stakeholders with different interests and agendas, using your great communication and collaboration skills. We would enjoy welcoming a straightforward person with a good sense of humour to our department. Finally, you meet own deadlines and know how to prioritise between different tasks in an everchanging environment.
About the department
Global Contract Manufacturing (GCM) QA is responsible for quality assurance and quality support to outsourced production activities worldwide. GCM QA is a dynamic department consisting of 70 competent people divided into 8 teams with focus on either operations or projects. You will be a strong player in the project team. The department is characterised by a high level of professionalism, flexibility, and cooperation. The primary role of our department is to deliver QA support and set direction for our global CMOs.
We focus on good social relations and prioritise to make room for fun at work. We have weekly quizzes, and we strive to have daily workout sessions to ensure on-going well-being in the team.
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 Lene Cletus Petersen on +45 3079 0412. Deadline
13th December 2023 You do not need to attach a cover letter to your application, but please include a few sentences about your motivation 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 "Produktchef", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 2.5.2023, 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.
- Produktchef
- Søborg
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