Compliance IT Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

Are you passionate about managing IT systems and ensuring compliance with high-quality standards? Do you have an interest in working with documentation, have an eye for detail, and for technical advisory? If so, we invite you to join Novo Nordisk A/S as an IT Responsible in Digital, Data & IT (DD&IT) in site Bagsværd.

This role offers a unique opportunity to become part of an exciting journey of building and scaling up our new department at one of the leading pharmaceutical companies in the world.

The Position

In this role, you will be responsible for ensuring a high level of compliance in IT documentation for several Computerized Equipment in our production facility. You will mainly support projects and new equipment but also contribute to life cycle management (LCM) on existing equipment documentation in the long run.

Key responsibilities include:

  • Being responsible for IT deliverables (most important ones being IT Risk Assessment, Operation & Maintenance SOP, ServiceNow registration, and IT recovery Plans) on new projects and equipment.
  • Operating and maintaining documentation on IT components within Computerized Equipment on our Filling Lines and in the Formulation area.
  • Developing and maintaining documentation to ensure compliance with internal and external regulatory frameworks & procedures.
  • Managing the stakeholder environment and expectations from different parties such as customers, System Owners, Data Owners, End-Users, Quality Assurance Staff, etc.
  • Representing the IT part of the Computerized Equipment and act as technical advisor towards stakeholders in the production and quality areas.

Qualifications

To succeed in this role, we are looking for someone with the following qualifications:

  • Master's or bachelor's degree within computer science, engineering or similar.
  • Around 2-3 years of experience in working with quality, preferably within IT systems in the pharmaceutical industry or other highly regulated GMP-compliant industry.
  • Experience in development and maintenance of IT systems, with background in production environment such as Safe Guard Systems (SGS) will be an advantage.
  • Excellent communication and interpersonal skills.
  • Fluency in written and spoken English, while proficiency in Danish will be an advantage.
  • As an advantage but not a requirement, you have validation experience.

About Us

At Novo Nordisk A/S, we employ more than 60,000 bright and diverse minds in 80 offices worldwide. We value our people and offer opportunities for personal and professional development. We strive to create an inclusive culture that celebrates diversity and recognizes its importance in driving innovation and success.



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