Senior Quality & Validation Specialist


Udlandet (øvrige)

Senior Quality & Validation Specialist

Would you like to be part of a fast-growing IT company dedicated to Pharma & Life Sciences? Do your passion lies within ensuring the Quality, Compliance and Validation, as well as setting direction and advising and training colleagues? Then here is a great opportunity to join the office in Søborg, Denmark in our newly established Global Quality & Qualification Services Team.

Your responsibilities as Senior Quality & Validation Specialist
You will be part of the Global Quality & Qualification team in Søborg. The team consists of 6 dedicated and skilled colleagues located both in Søborg and Tianjin in China. Our overall objectives are planning and executing Qualifications and Validation both for GxP and non-GxP systems, ensuring IT Infrastructure projects are in compliance with the existing regulatory requirements within the Life Science industry, as well as with NNIT’s internal quality assurance and control requirements. Furthermore, as trusted advisors, our focus is also to increase quality & awareness across the Global Projects Organization through training and other strategic initiatives.

Your primary responsibilities will be:

  • Organizing Quality Activities for Computer System Validation projects/activities (incl. areas related to Data Integrity/ER).
  • Facilitating and leading Qualifications .
  • Participating in projects as a Quality & Compliance advisor to ensure compliance and documentation requirements are met.
  • Reviewing IT project and operations documentation; ensure that process requirements are met according to internal QMS.
  • Identifying and implementing process improvements.
  • Help and assisting Line of Business with inspection readiness. Increasing quality awareness by training colleagues in regulatory requirements and NNIT’s Quality Management System.

Your qualifications
You have a university degree or similar higher education and have a solid experience working with validated computer systems, GxP and Quality Management.

You have experience working with one or more of the following; 21 CFR Part 11, PIC/S, Eudralex Annex 11 & 15, ISO9001 and have knowledge about GAMP5 framework. Furthermore it is an advantage if you have experience with ITIL or HP ALM (ver. 12).

You communicate well in English; both oral and written (English is our corporate language)

As a person you:

  • are structured in your daily work, self-motivated and able to take the initiative.
  • have effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.
  • are good at communicating and interacting with people.
  • prefer to work with various tasks simultaneously.
  • like to share your knowledge and help colleagues.
  • are used to work with creating and reviewing documentation.

We evaluate applications on a continuous basis, and therefore we encourage you to apply for the position as soon as possible.

Application deadline 31/12/2018

About NNIT


NNIT is a fast-growing IT company with ambitious goals. We supply IT services to large enterprises, the public sector and the life science industry - customers that demand high levels of quality and security.

At NNIT, you can make your mark on some of the most challenging projects in the IT industry, on our journey forward as a company, and on your own career.

We take on the responsibility for our clients' IT as if it were our own, and we live our values every day, so you should be able to see yourself in them. We are: Conscience driven. Value adding. Open and honest.

We regard diversity as a strength and support equal opportunities for all. We encourage applications from people of all ages, genders, religions and ethnic backgrounds.

Per Henriksen

HR Recruitment Partner

+45 30778364

Løbende ansøgningsfrist

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Udlandet (øvrige)
Kemi, Biotek & Materialer
Teknik & Teknologi
Data & analyse
IT - Hardware
IT - Netværk & Telekomm.
IT - Software
Medicinal & Sundhed

NNIT A/S - hurtigt overblik

IT advisory, development and operations with a strong focus on life sciences, finance, the public sector and large enterprises with equally high demands on quality and security.

Østmarken 3A
2860 Søborg
Logo: NNIT A/S
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