Quality Assurance Employee, responsible for IT validation across Lundbeck

Lundbeck Pharma A/S


Requistion ID: 508 Location: Copenhagen, N/A, DK

Date: 15-Aug-2019 Quality Assurance Employee responsible for IT validation across Lundbeck

Do you have experience from the pharmaceutical industry? And would you like to help ensure the quality and compliance of IT systems across Lundbeck’s production and research?
At Lundbeck, the way we use IT can have direct impact on the quality of the medicine that people depend on daily. It is the mission of Corporate QA IT to ensure the quality of those IT systems. You will help determine and mitigate the potential risks involved in implementing new IT systems and ensure that we comply with the requirements for quality and data integrity for both new and existing systems.

Welcome to Lundbeck’s Corporate Quality Assurance IT
At our office in Valby, Copenhagen, we are looking for a new colleague for the Corporate QA IT team which is part of Corporate Product Quality Assurance. Here, you will join 6 dedicated QA colleagues working to make sure that the computer systems in Lundbeck comply with internal and industry quality requirements.

Perform IT validation across the entire organisation
Employing critical thinking and your good sense of quality, you will help validate the use of new and existing IT systems to ensure compliance with the regulative framework. Doing so, you can be working with IT, production, distribution and research and collaborate with users across the organisation.

Depending on your strengths and interests, you can be involved with e.g.:

  • Developing and implementing validation strategies for specific IT systems, focusing on business processes and data integrity
  • Helping users throughout the organisation write validation documents
  • Helping identify, describe and mitigate potential data integrity risks related to the use of the IT system
  • Helping define possible solutions by clarifying requirements, technical specifications and procedures in close collaboration with users
  • Actively supporting users in testing and management of test deviations during validations and changes
  • Evaluating and approving validation documents / change requests for systems and infrastructure throughout the organisation
  • Performing internal audits of IT systems to ensure that guidelines are followed correctly and that risks are minimised
  • Helping develop and maintain our internal QA procedures and processes

A job with opportunities
Working with various aspects of computer validation, quality assurance and test management, you get to identify your strengths and interests and will have a chance to influence your future position and personal development. Your new team comes from different backgrounds and have different skill sets, so you will have plenty of opportunity to learn from your colleagues, and develop within a specialist area

Pharmaceutical profile with an interest in quality assurance
Many roads lead to this position: You may have experience with quality and compliance or risk-based computer validation within the pharmaceutical industry. Alternatively, you have experience from the pharmaceutical industry, e.g. as a laboratory technician, IT employee, pharmacists or a chemist, and you are now looking for an opportunity to work with IT quality assurance. Either way:

  • You have an eye for detail, and it comes naturally to you to employ critical thinking while navigating in a regulated framework
  • You have the power to make decisions when needed while at the same time being an excellent team player
  • You have the capacity to prioritize assignments and identify opportunities for improvement
  • You are self-motivated, structured and responsible with respect for deadlines and quality
  • You have a good understanding of IT at user level
  • You speak, read and write English on a high professional level – Speaking a Nordic language is an advantage

Further information
For further information, please contact Senior Manager Jesper Elkjær Rosendal on JER@lundbeck.com or +45 3083 2203.

We recommend that you have a look at our website: www.lundbeck.com.

Your application
Please click on the link below to apply for the job. Applications and CVs sent via email cannot be accepted. Applications must be received no later than 6. September 2019.

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Ansøgningsfrist d. 06.09.2019

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Medicinal & Sundhed
Teknik & Teknologi
Data & analyse
Forskning & Udvikling
IT - Hardware
Medicinal & Sundhed

H. Lundbeck A/S - hurtigt overblik

H. Lundbeck A/S
H. Lundbeck A/S
Lundbeck is a global pharmaceutical company specializing in psychiatric and neurological disorders

Ottiliavej 9
2500 Valby
Logo: H. Lundbeck A/S
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