IT Quality Specialist

Are you ready to play a key role and secure the quality of a digital transformation? We invite you to join a global pharma company with a local empowerment.

On behalf of our customer in Hillerød, Bloch & Buus is looking for an ITQ Specialist to join a QA- Drug Substance Manufacturing team. The branch in Hillerød is currently in the process of expanding Drug Product (DP) and Finished Goods (FG) capabilities as a Contract Development and Manufacturing Organization (CDMO).

Being a CDMO focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. The on-going digital transformation is an important strategic focus area in 2020 and we want you to participate.

The ITQ team and your new role
You will play an important role along with one other ITQ specialist as part of the QA team that currently includes 7 colleagues. All highly-skilled professionals who work in an open and honest atmosphere where focus is on cross-functional collaboration and transparency.

As a member of the IT Quality team, you will help to define, plan, and perform duties that support major system development life cycle activities, including validation review and change control approval of computerized GxP systems.

You will be responsible for the quality of IT changes, and the full SDLC. An important task is updating SOP’s, meet requirements and bring the right business value. The SOP update process also includes introduction and implementation of SDLC training to colleagues in the QA- and IT department. 

Your qualifications
We are on the lookout for someone who is eager to participate on business critical ITQ projects in an organization that is aiming to become more agile and flexible than ever before. Ensuring a high focus on quality is your job and by doing so, you can expect to further develop your skills along the way.

When we meet you during an interview, we will be curious to get to know your skills and experience within below areas:

  • Experience within qualification and validation of IT-platforms and applications
  • Experience with GAMP5, GxP, Part 11 and ITIL
  • Insight in infrastructure
  • Experienced in visualizing and clarifying important information to stakeholders

You are structured by nature and persistent until the job is done. Given your skills and experience you have a good overview and know how to prioritize your tasks.

As you will be working in an international environment, fluent English written and spoken it considered a must. 

You will be part of
An exciting opportunity to make your personal mark on an exciting digital transformation. This is an organization that highly prioritizes professional- and personal development. We can therefore guarantee that your ability to navigate will not be limited to your job title. It is a role that you can help define with your ambitions and skills. Did we forget to mention that you also get great colleagues? The team ranges between age 27-55 and works in a modern facility.

You will be offered a competitive compensation package that includes pension and a bonus scheme.

Interested? Then please apply as soon as possible and do reach out to us if you have any questions. 

We look forward to hearing from you.

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Påkrævede kompetencer

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Insight in infrastructure
Vurder dine faglige kompetencer.
English (written and spoken)

Little experience
Fluent written and spoken
Experience within qualification and validation of IT-platforms and applications

No experience
Highly experienced
Experience with GAMP5, GxP, Part 11 and ITIL

No experience with any of them
Highly experienced with all of them
Experience in visualizing and clarifying important information to stakeholders

No experience
Highly experienced
Arbejdssted:
Bloch & Buus kunde
.
3400 Hillerød
Danmark
Virksomheden tilbyder:
Fuldtid
Kategorier:
IT og drift
Indrykket:
13. februar 2020
Ansøgningsfrist:
27. februar 2020
Kontakt:
Kristian Bloch Sørensen
Telefon: 53861550