Senior Quality & Validation Specialist for NNIT Czech Republic
NNIT
Prague, Czech Republic
před 4 dny

Would youlike to be part of a fast-growing IT company dedicated to Pharma & Life Sciences?Do your passion lies within ensuring the Quality, Compliance and Validation, aswell as setting direction and advising and training colleagues?

Then here is agreat opportunity to join our newly established Global Quality & QualificationServices Team in NNIT Czech Republic.

Yourresponsibilities as Senior Quality & Validation Specialist

You will bepart of the Global Quality & Qualification team. The team consists of 6dedicated and skilled colleagues located in Denmark and China, and we are nowexpanding our Global team in the Czech Republic.

Our overall objectives areplanning and executing Qualifications and Validation both for GxP and non-GxPsystems, ensuring IT Infrastructure projects are in compliance with theexisting regulatory requirements within the Life Science industry, as well aswith NNIT’s internal quality assurance and control requirements.

Furthermore,as trusted advisors, our focus is also to increase quality & awarenessacross the Global Projects Organization through training and other strategic initiatives.

Your primaryresponsibilities will be :

  • Organizing Quality Activities for Computer System Validation projects / activities (incl. areas related to Data Integrity / ER)
  • Facilitating and leading Qualifications
  • Participating in projects as a Quality & 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
  • Yourqualifications

    You have auniversity degree or similar higher education and have a solid experience workingwith validated computer systems, GxP and Quality Management.

    You havedocumented experience working with 21 CFR Part 11, PIC / S, EU GMP Annex 11 &15, ISO9001 and have knowledge about GAMP5 framework.

    Furthermore it is anadvantage if you have experience with ITIL or HP ALM (ver. 12). You communicate well in English; both oral and written.

    As a person you :

  • are structured in your daily work, self-motivated and able to take the initiative
  • have effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information / instructions accurately
  • are good at communicating and interacting with people
  • prefer to work with various tasks simultaneously
  • like to share your knowledge and help colleagues
  • are used to work with creating and reviewing documentation
  • Employeebenefits

    We offer anattractive salary package according to your experience and seniority. Yourdedication and results are additionally rewarded with personal performancebonuses.

    We also offer you :

  • Theopportunity to work in a multicultural company
  • Friendly anddynamic work environment
  • Educationalcourses & training
  • Opportunitiesto learn and grow within a company or in other areas like soft skills,leadership, etc.
  • Mealvouchers
  • MultiSport cardenabling free entry to 362 sport facilities in Prague
  • Cafeteria
  • Flexiblestart / end of working hours
  • Occasionalwork from home
  • Foreignbusiness trips
  • Languagecourses of Czech for foreigners
  • Fresh fruitand tea / coffee in the office
  • CorporateEvents (Friday breakfasts, Friday bars, Kick-off party, Summer party)
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