SAP EWM Validation Lead

at  Novo Nordisk

SAP EWM Validation Lead
Category: Digital & IT
Location:Bagsværd, Capital Region of Denmark, DK
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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!

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 inspection

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 advantag