Quality Assurance for Aseptic CMO's - Søborg, Danmark - Novo Nordisk

Beskrivelse

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.

• 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.

• 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.