Compliance and Validation Consultant
NNIT
Prague, Czech Republic
před 1 dnem

Wouldyou like to be part of a fast-growing IT company dedicated to Pharma & LifeSciences? Does your passion lies within ensuring the Quality, Compliance and Validation,as well as setting direction and advising and training colleagues?

Then here isa great opportunity to join our Global Compliance & Validation ServicesTeam in NNIT Czech Republic.

Aboutyour new team

Youwill be part of the Global Compliance & Validation team that is currently expandingin the Czech Republic. Our overall objectives are planning and executing Qualificationsand Validation both for GxP and non-GxP systems, ensuring IT Infrastructureprojects are in compliance with the existing regulatory requirements within theLife 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 CzechRepublic
  • 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
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