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Experienced CSV Consultant, Germany


Would you like to be part of a fast-growing IT company dedicated to Pharma & Life Sciences? Does your passion lie within ensuring the Quality, Compliance and Validation, as well as setting direction and advising and training colleagues? Do you want to take your skills to the next level? Do you want to part of cutting-edge technology projects?

Take the step with us and join NNIT’s Compliance, Test & Validation team who is one of the leading teams in Europe when it comes to providing services of GxP regulated compliance and IT validation to the Pharmaceutical, Biotechnology, Life Science industry.

We are passionate people building winning teams with our customers. With deep roots in the pharmaceutical industry, we supply services that meet the highest requirements for quality, security and standardization. In addition to taking responsibility for complex consulting services in large IT development projects, we also provide customers with strategic advice on compliance with regulatory requirements and process improvements of IT systems, ongoing maintenance and operation.

Join us in NNIT and make your mark on a fast-growing IT company!

You will be part of our Compliance, Test & Validation team

It is important for us that you continuously develop both personally and professionally. Therefore, we focus on your skills through interesting assignments, relevant professional training and personal development plans.

What are you responsible for?

  • Independently orchestrating and managing validation projects for our clients,
  • Participating in projects as a Validation & Compliance advisor to ensure compliance and documentation requirements are met,
  • Creating and reviewing validation documents,
  • Assisting the project manager with quality and risk management issues,
  • Organizing Quality Activities for Computer System Validation (CSV) projects/activities (incl. areas related to Data Integrity/ER),
  • Customizing the system, or adapting the process, to comply the GMPs
  • Facilitating and leading E-2-E Validations,
  • Reviewing IT project and operations documentation; ensure that process requirements are met according to internal QMS,
  • Identifying and implementing process improvements,
  • Ability to work strategically and independently with internal and external groups on multiple simultaneous projects.

What do you bring with you?

  • 5+ years of experience as a CSV Consultant/ IT Engineer in Pharmaceutical, Biotechnology, Life Science industry
  • Solid experience in quality management of IT applications, Operating System, Infrastructure and Networking
  • Excellent communication skills and fluent English and German, both spoken and written,
  • Experience with working with validated computer systems (CSV) in GMP and Quality Management,
  • Good knowledge of ISPE GAMP5, FDA CFR 21 Part 11, EU GMP Guide Annex 11, OECD No. 17,
  • Experience preferred in implementing specific interfacing equipment in Production, such as Track & Trace, Blending, Encapsulation, Tablet Press, Room Monitoring System and other various equipment used for the manufacturing, packaging and Quality Control of drug products.
  • Experience with creating and reviewing documentation,
  • Team spirit,
  • Mobility.

What is in it for you?

  • Competitive salary, additional bonus and benefit package (contribution to your home internet, fitness funding, and others)
  • A dynamic workplace with good working conditions, social activities, and work life balance,
  • The opportunity to work in a multicultural company with a friendly and dynamic work environment.

We interview candidates continuously. Therefore, we encourage you to submit your application as soon as possible.

Application deadline:
30 Sep 2020

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Ansøgningsfrist d. 30.09.2020
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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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