Compliance and Validation Consultant

NNIT

Prague, Czech Republic

před 3 dny

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 workday (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 from Monday to Thursday

Wide selection of tea and coffee for free

Yoga classes in the office on Mondays

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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