Compliance and Validation Consultant

NNIT A/S

Fuldtidsjob
Udlandet (øvrige)

Compliance and Validation Consultant

Would you like to be part of a fast-growing IT company dedicated to Pharma & Life Sciences? Does 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 our Global Compliance & Validation Services Team in NNIT Czech Republic.

About your new team

You will be part of the Global Compliance & Validation team that is currently expanding in the Czech Republic. 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.

What will you be responsible for?

  • Organizing Quality Activities for Computer System Validation projects/activities (incl. areas related to Data Integrity/ER)
  • Facilitating and leading E-2-E Validations
  • Participating in projects as a Validation & 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
  • Helping and assisting Line of Business with inspection readiness
  • Increasing quality awareness by training colleagues in regulatory requirements and NNIT’s Quality Management System

What do you bring with you?

  • Experience with working with validated computer systems, GxP and Quality Management
  • Documented experience working with 21 CFR Part 11, PIC/S, EU GMP Annex 11 & 15, ISO9001
  • Knowledge about GAMP framework
  • Experience with creating and reviewing documentation
  • Excellent communication skills and fluent English, both spoken and written

Employee benefits

• 5 weeks of vacations/year

• 5 sick days/year

• Flexible working hours

• Cafeteria flexible spending account (12,000 CZK/year)

• Meal vouchers in the amount of 100 CZK per work day (55 CZK is covered by NNIT)

• Fully covered MultiSport card enabling free entry to sport facilities in Czech Republic

• Free breakfasts on Fridays and monthly Friday Bars (free beer and snacks)

• Free fruits and vegetables on Mondays and Wednesdays

• Wide selection of tea and coffee for free

• Yoga classes in the office on Mondays and Thursdays

• Height adjustable tables, relax zones with Xbox, PlayStation and ping pong

• Czech and Danish language lessons

• Annual flu vaccination for free

Application deadline

About NNIT

IT ADVISORY, DEVELOPMENT & OUTSOURCING

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.

Contact
Katerina Zajickova

HR Consultant

+420 770 141 359


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Fuldtidsjob
Udlandet (øvrige)
IT
Kemi, Biotek & Materialer
Teknik & Teknologi
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IT - Software
Medicinal & Sundhed
Produktion



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.

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Østmarken 3A
2860 Søborg
Logo: NNIT A/S
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