Outsourcing QA Coordinator
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Are you passionate about working with coordination and ensuring compliance? We are looking for a new Outsourcing QA Coordinator to join our department and take responsibility for some of our Outsourcing activities across CMC Development & Scaling.
The position
In this position you will work closely with our QPs and Auditors, the different CMCQA departments, various stakeholders, everything to ensure a compliant outsourcing process. The key responsibilities of this position includes: IMP Outsourced activities and Audit coordination activities such as: Maintain IMP (Investigational Medicinal Products) list of Contract Acceptors. Work closely with QA Outsourcing Managers within selection and approvals of new Contract Acceptors. Work closely with QPs in CMC Development within approving of new Contract Acceptors. Coordinate external audits at Contract Acceptors. Work closely with Supplier Audits in order to coordinate audits across. Improve the existing process within CMOs and external audits in order to optimize and clarify roles and responsibilities.
Qualifications
An important qualification is your interest and drive for a systematic approach, as well as an eye for details and improvements.
To be successful in this role, we expect you to have: A technical/manufacturing background or experience within the GMP regulated industry. Experience with coordinating – and preferably some knowledge of Outsourcing. Strong stakeholder management skills and the ability to communicate on all levels of the organization. Can work highly independently. The candidate must be fully proficient in both English and Danish.
On a personal level you are proactive with a curious and pragmatic approach. You will be able to build strong relations to have solid cooperation across the different areas. You thrive in an environment with many stakeholders where you need to navigate at all levels in the organization.
About the department
You will be joining a small department of 6 employees, whose main responsibility is to support CMC QA with a variety of tasks. The 6 of us are specialized in different areas and tasks, but we are also always willing to help each other to solve tasks across CMC QA. 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 Senior QA Project Manager, Mette Juhler at +45-30755578.
Deadline
20 August 2024.
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. 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 work closely with our QPs and Auditors, the different CMCQA departments, various stakeholders, everything to ensure a compliant outsourcing process. The key responsibilities of this position includes: IMP Outsourced activities and Audit coordination activities such as:
Qualifications
An important qualification is your interest and drive for a systematic approach, as well as an eye for details and improvements.
To be successful in this role, we expect you to have:
On a personal level you are proactive with a curious and pragmatic approach. You will be able to build strong relations to have solid cooperation across the different areas. You thrive in an environment with many stakeholders where you need to navigate at all levels in the organization.
About the department
You will be joining a small department of 6 employees, whose main responsibility is to support CMC QA with a variety of tasks. The 6 of us are specialized in different areas and tasks, but we are also always willing to help each other to solve tasks across CMC QA. 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 Senior QA Project Manager, Mette Juhler at +45-30755578.
Deadline
20 August 2024.
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. 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 Bagsværd.
Jobbet er oprettet på vores service den 6.8.2024, 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.
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