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
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