- Executing documentation and procedures to support standardization efforts
- Ensuring alignment of documents and templates with NN validation process, from Science- and Risk-based approach to validation, in line with the Fill & Finish Expansion (FFEx) Quality strategy
- Driving the implementation of documentation standards across various programs and projects
- Collaborating closely with internal FFEx program organization and specialists
- Communicating efficiently with stakeholders at all levels to ensure alignment and transparency
- Hold a minimum of a bachelor's degree in a relevant field
- Possess hands-on experience in validation within the pharmaceutical or medical devices industry
- Demonstrate in-depth knowledge with regulatory requirements for validation, including drug, combination, and device products
- Showcase a keen understanding of validation processes and ensuring compliance with relevant internal and external regulatory standards
- Display proficiency in both spoken and written English
Validation Specialist - Hillerød, Danmark - Novo Nordisk A/S
Beskrivelse
Are you experienced in validation of Finished Product processes within the pharmaceutical industry? Do you thrive collaborating in a dynamic environment and are committed to delivering stellar results?
If so, this is your moment. Join us in Device Manufacturing Development (DMD) Assembly & Packaging (A&P), a department where your impact matters. Seize the chance and apply today for a life-changing career.
The position
As Validation Specialist, your role involves close collaboration with manufacturing organizations in Novo Nordisk as well as a large portfolio of project teams in DMD. Your primary responsibility is to develop modern approaches to validation that ensures harmonization and simplification across A&P.
Your key tasks entail:
Qualifications
To be successful in this role, we believe you:
On a personal level, you possess exceptional communication skills, are adept at negotiation, and seamlessly connect with stakeholders. You excel in navigating diverse perspective and orchestrating decisions that align with the best interest of everyone involved, even in high-risk situations or when faced with differing opinions. You are not just a team player but also an inspiration, transforming challenging into opportunities for the team's and business' success.
About the department
You will join DMD and the A&P department, a key function supporting assembly and packaging of Novo Nordisk finished products, primarily pen injectors and tablets. We are bridging product development to production and driving development and standardization of new, smarter, and aligned processes.
Furthermore, we are responsible for establishing assembly and packaging capacity worldwide for new and marketed products in compliance with current regulatory requirements and in close interaction with the Novo Nordisk global production sites. We have an end-to-end presence from device development to production implementation and support to running production.
We are located in Hillerød and are a department that is growing rapidly, consisting of over 150 employees placed into different teams. At the office, we share an informal tone, great work morale and tall ambitions to be the best at what we do. Once you step into this role, you will join a diligent and highly competent team and be at the crossroad between Device and Delivery Solutions, Quality, and Production.