Quality Assurance Specialist

3 weeks ago

Kongens Lyngby, Lyngby-Tårbæk Kommune, Denmark Novo Nordisk AS Full time

Are you driven to ensure the quality and compliance of life-saving medicines? Do you thrive in a dynamic and changeable environment where focus is on delivering high-quality products to our patients?

If yes, then you might be the ideal candidate for this role at Novo Nordisk.

The Position

We are seeking a highly skilled and detail-oriented Validation and Compliance Specialist to join our intralogistics team. The ideal candidate will play a critical role in ensuring the validation and compliance of our intralogistics systems, adhering to industry standards and regulations.

In this role, you will have the following responsibilities:

  • Develop and implement validation protocols and procedures for intralogistics systems, including material handling equipment, warehouse management systems, and automated storage solutions.
  • Conduct risk assessments and validation activities in accordance with regulatory requirements.
  • Collaborate with engineering and operations teams to perform validation testing, analyze results, and address any non-conformities or discrepancies.
  • Ensure compliance with safety, quality, and environmental standards, while also participating in continuous improvement initiatives to enhance intralogistics processes.

Qualifications

To be successful in this role, we are looking for a candidate with the following qualifications:

  • Bachelor's degree in engineering, supply chain management, or a related field. A master's degree is preferred.
  • Proven experience in validation and compliance within intralogistics, logistics, or supply chain operations.
  • Strong understanding of industry regulations and standards, such as FDA regulations, GAMP guidelines, and ISO 9001.
  • Excellent analytical and problem-solving skills, with the ability to interpret technical requirements and apply them to validation processes.
  • Exceptional communication and collaboration abilities, with a keen attention to detail and a commitment to delivering high-quality results.

As a person, you are responsible and able to execute necessary decisions to solve challenges with flair for efficiency and quality. It is essential that you thrive in a challenging, dynamic, and changeable environment and are willing to take on tasks of varying sizes.

Your workplace will be based in Lyngby, but as there is collaboration required on a global scale with our sites based in Europe, China, and the US, some international travel will be required. It is estimated that this will be a few days per month, with occasional prolonged periods of travel.

About the Department

Fill & Finish Expansions Intralogistics belongs to the newly established Fill & Finish area. The new area is working to increase the aseptic production capacity across the Novo Nordisk network to ensure we continue to deliver high-quality products for our patients, also in the future.

You will be part of a team that works in a vibrant and positive working environment and values the exchange of knowledge and experience. Networking and cooperation are key to our success.

You will refer to Senior Manager Martin Ullitz, who is an experienced people manager and values a working framework based on mutual trust. He leads through coaching, involvement, and empowerment of employees, and psychological safety, which creates a healthy learning environment where employees can grow and evolve personally and professionally.

To learn more about Fill & Finish Expansions in Novo Nordisk, visit our career site here: Let's build the future for patients: Exciting Careers in Growing Expansion Project (novonordisk)

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