Compliance and Validation Consultant
At Monster Career, we enjoy connecting smart professionals with new challenging projects! To do so, we’re cooperating with a leading consultancy company working in the fields of IT development, implementation, and operations focused on the financial and pharmaceutical industries.
About the company
The client is a fast-growing IT company with ambitious goals. They supply IT services to large enterprises, the public sector and the life science industry – customers that demand high levels of quality and security.
Here, you can make your mark on some of the most challenging projects in the IT industry, on their journey forward as a company, and on your own career.
They take on the responsibility for their clients’ IT as if it would be their own, and we live their values every day, so you should be able to see yourself in them. They are: Conscience driven. Value adding. Open and honest.
They regard diversity as a strength and support equal opportunities for all. We encourage applications from people of all ages, genders, religions and ethnic backgrounds.
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 the company`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 workday (55 CZK is covered by the company)
• 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