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QA Lead - Data Integrity

NNIT A/S



Quality Lead - GxP Data Integrity

Responsibilities

Lead a global Laboratory Information Systems (LIMS) team in the implementation and management steady state support for Data Integrity (DI), specifically:

  • Assessment of existing systems devolvement of mitigations, both general and specific, to the FDA’s DI guidance and other regulatory bodies’ DI recommendations
  • Provide the team with strong working knowledge of computer system validation and system support practice.
  • Develop and present associated metrics to senior management
  • Create training materials for and provide training for corporate DI remediation efforts
  • Work with the team to define a core of specific user requirements to address DI compliance
  • Update existing specifications and related SOPs to include new DI related requirements

Qualifications:

  • Experience as leader in a dynamic IT QA environment
  • BSc in a scientific field and / or related work experience in the SDLC
  • Experience in Computer Validation / Data Integrity with a strong understanding of GAMP, 21 CFR Part 11, as well as related EU regulation and guidance.
  • Ability to understand various enterprise systems being used in a regulated environment, and the impact of propose DI solutions on multiple stakeholders
  • Self-starter with excellent oral and written communication skills.

About NNIT
NNIT is a leading global consultancy specializing in IT development, implementation, and operations for the life sciences industries. Having started life as the IT department of Novo Nordisk- Denmark’s largest pharmaceutical firm- we have pharmaceuticals and devices in our DNA. Independent for over a decade, today, NNIT has more than 2,800 employees - around 1,200 employees work outside the borders of Denmark - in China, the Czech Republic, the Philippines, Switzerland and in the US.

We are 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.

Application deadline:
15 Oct 2020

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Ansøgningsfrist d. 15.10.2020
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Udlandet (øvrige)
Uddannelse
IT
Kemi, Biotek & Materialer
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Data & analyse
Forskning & Udvikling
IT - Software
Medicinal & Sundhed
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Rådgivning & Support
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NNIT A/S - hurtigt overblik


NNIT A/S
NNIT A/S
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.

Placering
Østmarken 3A
2860 Søborg
Logo: NNIT A/S
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