Advanced QA Professional
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Søborg
We are looking for a QA professional like you, with a high level of dedication, communication skills and quality mindset. Are you ready to engage, support and collaborate with colleagues in an international business environment? Then, you could be our new QA for Contract Manufacturing Organization (CMO) in Østmarken, Søborg (our department will be moving to new office buildings in Taastrup by the end of 2024). Global Contract Manufacturing (GCM) QA is responsible for quality assurance and quality support for outsourced production activities worldwide.
The position
You will have the opportunity to make a difference for thousands of patients around the world by ensuring a high level of quality of the products of Novo Nordisk. As QA Professional you will be responsible for quality assurance of contract manufacturing for aseptic CMO’s producing drug products (DP). Your main tasks will be to: Provide support and guidance to our stakeholders and CMO’s Perform review of batch documentation and final release Approve of documentation such as changes and deviations for aseptic drug products from CMO’s.
You will have numerous encounters daily with both internal and external business partners and you should expect a high level of complexity in your daily tasks. The daily QA activities are typically carried out by the contract manufacturers themselves, but the handling of documentation from the contract manufacturers is a part of the job as well as release of batches from Novo Nordisk.
Since the manufacturers are located outside Denmark, you are expected to travel 5-15 days a year.
Qualifications To succeed in this role you: Hold a master’s degree as Pharmacist, Biology, Veterinarian or similar Have at least 3 years of experience from a pharmaceutical organization in a similar position Have solid and up-to-date knowledge of quality and GMP requirements i.e. Deviations (DV), Corrective Actions and Preventive Actions (CAPA) handling, change control, complaints, Annual Product Review (APR) and validations. Are fluent in oral and written English.
The ideal candidate is Qualified Person delegate (QPd) and/or has thorough knowledge of aseptic production and/or experience from working as QA for CMO’s.
With your good cooperation and communication skills you are able to organize and drive tasks. You have a pragmatic approach to problem solving and strong interpersonal skills. You are detail-oriented with a strong quality mindset and are a team player but are also able to work independently. You thrive on working across departments in an international organization.
About the department
GCM QA is a dynamic department consisting of 45 competent people and is characterized by a high level of professionalism, flexibility, and collaboration. The primary role of our department is to deliver QA support and set direction for our Global Contract Manufacturer Organizations worldwide. The open position as QA Professional is in the GCM QA Operations Drug Product Aseptic team, which is responsible for aseptic production at the CMO´s. Working at Novo Nordisk
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. Contact
For further information, please contact Linea Frenk Alsing (LRFA) on +45 3075 6596
Deadline
Apply before July, 9 2024. We will review applications on an ongoing basis, so do not hesitate to apply today. 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 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
You will have the opportunity to make a difference for thousands of patients around the world by ensuring a high level of quality of the products of Novo Nordisk. As QA Professional you will be responsible for quality assurance of contract manufacturing for aseptic CMO’s producing drug products (DP). Your main tasks will be to:
You will have numerous encounters daily with both internal and external business partners and you should expect a high level of complexity in your daily tasks. The daily QA activities are typically carried out by the contract manufacturers themselves, but the handling of documentation from the contract manufacturers is a part of the job as well as release of batches from Novo Nordisk.
Since the manufacturers are located outside Denmark, you are expected to travel 5-15 days a year.
Qualifications To succeed in this role you:
The ideal candidate is Qualified Person delegate (QPd) and/or has thorough knowledge of aseptic production and/or experience from working as QA for CMO’s.
With your good cooperation and communication skills you are able to organize and drive tasks. You have a pragmatic approach to problem solving and strong interpersonal skills. You are detail-oriented with a strong quality mindset and are a team player but are also able to work independently. You thrive on working across departments in an international organization.
About the department
GCM QA is a dynamic department consisting of 45 competent people and is characterized by a high level of professionalism, flexibility, and collaboration. The primary role of our department is to deliver QA support and set direction for our Global Contract Manufacturer Organizations worldwide. The open position as QA Professional is in the GCM QA Operations Drug Product Aseptic team, which is responsible for aseptic production at the CMO´s. Working at Novo Nordisk
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. Contact
For further information, please contact Linea Frenk Alsing (LRFA) on +45 3075 6596
Deadline
Apply before July, 9 2024. We will review applications on an ongoing basis, so do not hesitate to apply today. 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 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 Søborg.
Jobbet er oprettet på vores service den 25.6.2024, 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
- Søborg
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