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