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Quality Assurance for Aseptic CMO's - Søborg, Danmark - Novo Nordisk A/S - VTx
Beskrivelse
Global Contract Manufacturing (GCM) Quality Assurance (QA) is responsible for quality assurance and quality support for outsourced production activities worldwide. 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, where we both have collaboration internal and with CMO's?
Then you could be our new colleague in GCM QA, located in Østmarken, Søborg (Please note that our department will be relocating to new office buildings in Taastrup by the end of 2024).
The position
Global Contract Manufacturing (GCM) QA is responsible for quality assurance and quality support for outsourced production activities worldwide. 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:
• Ensuring quality assurance of contract manufacturing for aseptic CMO's producing drug products (DP).
• Providing support and guidance to stakeholders and CMO's.
• Reviewing batch documentation, final release, and approving changes and deviations for aseptic drug products from CMO's as a key task.
• Engaging in frequent interactions with internal and external business partners, involving a high level of complexity in daily tasks.
• Overseeing daily QA activities typically conducted by contract manufacturers, as well as managing documentation from contract manufacturers and the 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 should:
• Hold an academic degree in Pharmacy, Biology, Veterinary Science, or a related field.
• Possess a minimum of 3 years of experience in a pharmaceutical organization.
• Demonstrate a solid and up-to-date understanding of quality and GMP requirements, including handling of Deviations (DV), Corrective and Preventive Actions (CAPA), change control, complaints, Annual Product Review (APR), and validations.
• Ideally, be a Qualified Person delegate (QPd) and/or have extensive knowledge of aseptic production or experience working as a QA for CMOs.
As a person, you possess strong cooperation and communication skills, and you are capable of organizing and driving tasks. You exhibit a pragmatic approach to problem-solving, along with strong interpersonal skills. You are detail-oriented with a strong focus on quality, and demonstrate the ability to work both as a team player and independently. You excel in working across departments within an international organization.
About the department
GCM QA is a dynamic department consisting of 50 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
Deadline
28 April 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.
