Validation Lead WareX (Denmark, Ballerup)

Jobbeskrivelse
Placering
Ballerup, Denmark

Jobkategori
Digital & IT

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Do you have a strong drive and excellen quality/validation skills? Do you want play a key role in defining and leading validation strategy, to drive efficiency across Novo Nordisk production?

If so, you could be our new Validation Lead!

What’s in it for you
We are on an exciting journey in rolling out SAP EWM, a Warehouse Management System (WMS), at various sites in Novo Nordisk and you will have the opportunity to play a vital role in securing production efficiency and speed for the next many years. As a WareX Validation Lead, you will play a crucial role in ensuring the validation and compliance with regulatory requirements of our complex system landscape, and driving continuous improvement through innovative validation and qualification strategies.

Your responsibilities will include:

• Defining and executing validation and qualification strategies for WareX and in a portfolio of projects
• Effective communication to build strong relations with colleagues and stakeholders at all levels in the organization, including facilitating workshops and trainings
• Conduct end-to-end validation and qualification activities, including making validation plans and reports, risk assessments, design review, test strategy and execution etc.
• Ensuring that systems are in compliance with relevant internal and external regulatory requirements, while also participating in continuous improvement initiatives within the area
• Participate in audits and inspections including finding solutions to compliance gaps identified in audits and inspections

What we scout for:
To be successful in this role, we prefer you have a degree within Engineering, Chemistry, Pharmacy, IT or similar and at least 5 years of experience in any of the following:

• Proven experience in validation and compliance of IT System Validation
• Logistics/Manufacturing/production experience or a recognized GMP certificate or qualification
• Strong understanding of industry regulations and standards, such as FDA regulations, GAMP guidelines, and ISO 9000
• Fluent in written and spoken English, Danish is an advantage

As a person you have a pragmatic mindset, you are solution oriented and able to execute necessary decisions to solve challenges with a quality mindset. You are able to drive continuous improvement, in a dynamic and highly complex stakeholder environment. You can communicate effectively with technical and non-technical stakeholders, using clear and concise language and you have excellent written communication skills for creating and maintaining validation documentation and instructions. When solving your tasks you use your strong analytical and problem-solving skills, with attention to detail, and a structured approach to validation and qualification activities. To ensure executing of validation plans and test strategies within project timelines, you use your time management skills and your mathematics skills for performing various assessments.

The team waiting for you
The department, WareX is anchored in DD&IT Supply Chain and is focused on implementing EWM – a Warehouse Management System (WMS), used across Novo Nordisk. We set the strategic direction and ensure that processes across production lines are automated and optimized. The team is primarily located in Bagsværd (Greater Copenhagen area), Denmark, and work hand-in-hand with our Product Supply colleagues, meaning that you will get to work closely with the users and technologies that drive our global manufacturing processes to the next level.

The WareX program at Novo Nordisk is a strategic initiative aimed at enhancing our global supply chain operations through the deployment of advanced digital solutions. This program focuses on implementing the SAP EWM solution across all Novo Nordisk production sites worldwide. By leveraging cutting-edge technology, WareX aims to improve operational efficiency, streamline processes, and ensure seamless integration of our supply chain activities. The goal is to enhance our ability to deliver high-quality products to patients around the globe, while maintaining the highest standards of safety and compliance.

Join the Novo Nordisk family
Founded in Denmark in 1923, Novo Nordisk has become one of the world’s leading healthcare companies. At Novo Nordisk, we are committed to driving change to defeat diabetes and other serious chronic diseases. To fulfil this purpose, we pioneer scientific breakthroughs, expand access to our medicines, and work to prevent and ultimately cure disease. That said, we are anything but linear.

With us, your skills, commitment, and ambition help us change patients’ lives worldwide. In exchange, we offer you a rewarding and purpose-driven culture with talented and diverse co-workers. Therefore, your professional and personal development is essential for us, and in Novo Nordisk, the sky is the limit for career opportunities.

Every day, our thousands of digital experts work in all areas of technology. We navigate the tech spectrum from front-end to back-end, from artificial intelligence to machine learning, and from cloud systems to quantum computing. All to make a tangible impact on lives across the globe. How? Go explore at TechLife at Novo Nordisk.

Any questions?
For further information, contact Linda Høyer, Agile People Leader, [email protected]

Deadline
30 November 2024

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Feeling overwhelmed by job requirements and doubting if you're 100% qualified? Don't let it stop you! We encourage you to apply anyway, as your profile could surprise us and fit our needs better than you think. So take the leap and submit your application.

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