Quality Specialist - Recalls, Inspection Office
Bagsværd
Do you have substantial experience working in GMP-regulated areas? This expertise could stem from your role as a Quality or production specialist. The key is to have a strong focus on quality, excel in managing tasks related to quality and compliance with multiple stakeholders, and be skilled at handling urgent deadlines and planning.
Currently, we are seeking new team members in the Inspection Office to strengthen the team responsible for managing Recall situations. The position
You will get the opportunity to work within an area with high management attention in . The deliverables of our team are significant in ensuring quality for our patients and the job will surely challenge and develop your business understanding.
Your primary responsibility will be : Lead the coordination of recalls or potential recall situations for products. Oversee recalls in close cooperation with relevant health authorities and stakeholders across . You will be part of a team of six dedicated colleagues and report to the Recalls Senior Manager and the team is a part of Quality Inspection Office. Qualifications
To be successful in this role, you need the following: An academic degree in engineering, pharmaceutical sciences, or a related natural science discipline. Experience with quality assurance or production in the pharmaceutical industry within e.g. filling, assembly or packaging, Strong communication skills; both verbal and written communication across all levels of the organization both internally and externally. Fluency in English - both written and spoken, and be an experienced user of MS Office. Preferably you have experience with: organisation and prouduct portfolio. Handling change requests, deviations and systematic problem solving. Being a part of a potential recall case or responsible for escalated deviations. Communication to Health Authorities. As a person you are analytical, with a calm and professional authority and have a flexible working attitude. You thrive with working across business areas, facilitating various groups and with business-critical tasks and project with short deadlines. We expect you to be a team player and have a natural interest in quality processes, authority requirements and our obligations to patients world-wide.
About the department
Located in Bagsværd, Denmark, the department, Inspection Office is a highly specialised area where you will join a team of 22 highly skilled, ambitious, and motivated specialists with the responsibility for handling Recalls, GMP inspections and notified bodies audits in as well as responsibility for the corporate recall, batch records, review and release processes. We have a close collaboration with our stakeholders globally in Novo Nordisk spanning across manufacturing sites, affiliate offices and regulatory affairs, as well as with health authorities around the world. Working at At , 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 Julie Månsson, +. Deadline
16 June 2024. We will review applications received 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 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 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.
Currently, we are seeking new team members in the Inspection Office to strengthen the team responsible for managing Recall situations. The position
You will get the opportunity to work within an area with high management attention in . The deliverables of our team are significant in ensuring quality for our patients and the job will surely challenge and develop your business understanding.
Your primary responsibility will be :
To be successful in this role, you need the following:
About the department
Located in Bagsværd, Denmark, the department, Inspection Office is a highly specialised area where you will join a team of 22 highly skilled, ambitious, and motivated specialists with the responsibility for handling Recalls, GMP inspections and notified bodies audits in as well as responsibility for the corporate recall, batch records, review and release processes. We have a close collaboration with our stakeholders globally in Novo Nordisk spanning across manufacturing sites, affiliate offices and regulatory affairs, as well as with health authorities around the world. Working at At , 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 Julie Månsson, +. Deadline
16 June 2024. We will review applications received 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 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 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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