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Validation Responsible

4 months ago

Odense, Odense Kommune, Denmark Novo Nordisk AS - Nn1 Full time

Are you passionate about validation and building relationships across the organization? Are you interested in being a part of something bigger than yourself and contribute to the health of millions of people worldwide?

We are seeking a detail-oriented and experienced professional to fill the combined role of Validation Responsible and Operational Responsible to join our exciting new project. Apply now and join us


The Position

As a Validation Responsible, you will establish an overview of validation activities and priorities and ensure that our commissioning/qualification/validation documentation complies with Good Manufacturing Practices (GMP).

This position will involve overseeing validation activities as well as ensuring operational efficiency within our project organization. Your primary responsibilities will be:

  • Executing documentation and procedures to support standardization efforts.
  • Developing and executing validation protocols and reports.
  • Ensuring alignment of documents and templates with NN validation process, from Science- and Risk-based approach to validation.
  • Ensuring compliance with industry standards and regulations.
  • Driving the implementation of documentation standards across our projects.
  • Training other colleagues in different quality standards used in the project.

    You will also be responsible for communicating efficiently with stakeholders at all levels to ensure alignment and transparency and collaborating with cross-functional teams to streamline processes and workflows.

    The position as validation responsible can give opportunity to become area specialist, based on the experience of the candidate.

    You will be working from both Høje Taastrup and Odense.

    Qualifications

    To succeed in this position, we expect you to have:

    • An academic degree in a relevant field e.g., engineering, pharmaceutical sciences, or related disciplines
    • 5+ years of experience of validation and commissioning / qualification / validation from a pharmaceutical company.
    • Excellent communication skills with experience of working cross functionally and building relations with stakeholders at all organizational levels.
    • Full proficiency in written and spoken English. Danish will be advantageous.

      On a personal level, you bring a strong quality mindset and the ability to enforce it in a pragmatic way. You are self-driven and independent with a high sense of responsibility whilst enjoying working in a dynamic environment. Among your capabilities you show a proven ability to set direction as you are structured, detail-oriented, curious, good at planning and able to challenge. You have strong communication skills and thrive on engaging with people and building relationships, which includes the capability to manage various stakeholders effectively.

      About the department