Senior QA for QC Professional
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Nordsjælland
Are you keen on playing a crucial role in overseeing Quality Control processes in our global network of Contract Manufacturer Organizations (CMOs)? Do you thrive in a job with lots of professional interfaces working with projects with many stakeholders both within Novo Nordisk and at our CMOs? Then you could be our new colleague in Global Contract Manufacturing (GCM) Quality Assur-ance (QA) drug substance (DS) and we will look forward to welcoming you to our great team, read more and apply!
The position
In this position you will be QA responsible for the analytical methods implemented at Novo Nordisk CMO's. Your key task will be to ensure the quality of analysis and methods related to testing of out-sourced raw materials, intermediates and starting materials. You will participate in various projects working with both internal and external business partners and you must expect a high level of com-plexity and independent decision making in your daily tasks.
The job includes:
• QA review of analytical documentation from CMO's such as protocols and reports for meth-od validation.
• Communication with CMOs primarily via teleconferences.
• Keep up to date with changes in relevant guidelines and regulatory requirements.
Since the manufacturers are located outside Denmark a few travel days per year are expected.
Qualifications
To succeed in this role, you: hold an academic degree as Pharmacist, Chemist, Engineer or similar. have at least 5 years of experience within the pharma industry or similar. have a solid and up-to date knowledge of quality and GMP requirements. are fluent in English and preferably have a good Danish proficiency too.
On a personal level, you are an open-minded person with an outgoing attitude and natural network-ing skills, you take responsibility, work independently, and make decisions that balance quality de-mands, authority expectations and business needs. You meet your deadlines, and you know how to prioritize between different tasks in an everchanging environment.
Additionally, we would enjoy welcoming a straightforward person with a good sense of humor to our department.
About the department
GCM QA DS is responsible for quality assurance and quality support to outsourced DS production activities worldwide. GCM QA DS is a dynamic area consisting of 48 competent people divided into areas with focus on either operations, projects or QA for QC & System Support, You will be a strong player in the QA for QC & System Support team together with 3-4 other QA for QC professionals. The department is characterized by a high level of professionalism, flexibility, and cooperation. The pri-mary role of our department is to deliver QA support and set direction for our global CMOs.
You will join a team of fun and dedicated colleagues who come together to set direction and support GCM QA through its rapid journey of growth. We are office based. Collaboration with a diverse range of stakeholders internally and externally is crucial in order for us to succeed. We want to unleash the full potential of sustainable external manufacturing to reach more patients faster through flexible production and strong relations.
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 Manager Mia Ingemann de Lasson +. Deadline
5 January 2025. Interviews will be conducted on an ongoing basis, so we encourage you 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 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 QA responsible for the analytical methods implemented at Novo Nordisk CMO's. Your key task will be to ensure the quality of analysis and methods related to testing of out-sourced raw materials, intermediates and starting materials. You will participate in various projects working with both internal and external business partners and you must expect a high level of com-plexity and independent decision making in your daily tasks.
The job includes:
• QA review of analytical documentation from CMO's such as protocols and reports for meth-od validation.
• Communication with CMOs primarily via teleconferences.
• Keep up to date with changes in relevant guidelines and regulatory requirements.
Since the manufacturers are located outside Denmark a few travel days per year are expected.
Qualifications
To succeed in this role, you:
On a personal level, you are an open-minded person with an outgoing attitude and natural network-ing skills, you take responsibility, work independently, and make decisions that balance quality de-mands, authority expectations and business needs. You meet your deadlines, and you know how to prioritize between different tasks in an everchanging environment.
Additionally, we would enjoy welcoming a straightforward person with a good sense of humor to our department.
About the department
GCM QA DS is responsible for quality assurance and quality support to outsourced DS production activities worldwide. GCM QA DS is a dynamic area consisting of 48 competent people divided into areas with focus on either operations, projects or QA for QC & System Support, You will be a strong player in the QA for QC & System Support team together with 3-4 other QA for QC professionals. The department is characterized by a high level of professionalism, flexibility, and cooperation. The pri-mary role of our department is to deliver QA support and set direction for our global CMOs.
You will join a team of fun and dedicated colleagues who come together to set direction and support GCM QA through its rapid journey of growth. We are office based. Collaboration with a diverse range of stakeholders internally and externally is crucial in order for us to succeed. We want to unleash the full potential of sustainable external manufacturing to reach more patients faster through flexible production and strong relations.
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 Manager Mia Ingemann de Lasson +. Deadline
5 January 2025. Interviews will be conducted on an ongoing basis, so we encourage you 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 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 Nordsjælland
Jobbet er oprettet på vores service den 16.12.2024, 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
- Nordsjælland
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