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Advanced CSV Consultant


Advanced CSV Consultant

Would you like to be part of a fast-growing IT company dedicated to Pharma & Life Sciences? Does your passion lie within ensuring Quality and Compliance? Do you want to take your skills to the next level?

Take the step with us and join NNIT’s Compliance, Test & Validation team. We are 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?

  • Creation, review, and approval of validation/qualification documentation,
  • Coordination of infrastructure qualification projects (Server, Data Center, Network, Cloud),
  • Independently orchestrating and managing validation/qualification projects for our clients,
  • Participating in projects as a Validation & Compliance Advisor to ensure compliance and documentation requirements are met,
  • Monitoring and implementation of CAPA during periodic reviews,
  • Being a communication bridge between departments (IT, Business, Quality).

What do you bring with you?

  • +1 year of experience as a CSV Consultant/ IT Engineer in Regulated Industries,
  • Good knowledge of ISPE GAMP5, FDA 21 CFR Part 11, EU GMP Guide Annex 11,
  • Experience with creating and reviewing documentation,
  • Experience in IT Infrastructure Qualification and IT Service Management Procedures
  • Basic knowledge in standards ISO/IEC 20000 and 27000,
  • Ability to work on multiple smaller projects at the same time and properly prioritize actions,
  • Excellent communication skills and fluent English and/or German, both spoken and written,
  • 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, team events and work life balance,
  • Inspiring work environment with access to our global network and ample training opportunities,
  • Informal working culture between NNIT colleagues,
  • Opportunity to work in a multicultural company with a friendly and dynamic work environment,
  • Opportunity to work with the most significant life sciences clients,
  • Diversity of projects, and possibility of shaping your career path with the advisory of your Manager,
  • Personal development model which defines your long-term career goals, developed by you and your local Manager, and being implemented in your daily work activities.

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

Location: Frankfurt am Main (Germany)

Application deadline: 30 Sep 2021

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Ansøgningsfrist d. 30.09.2021
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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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