Validation Officer

vor 4 Wochen

Deutschland Türkei Schweiz Frankreich NTT DATA Business Solutions AG Vollzeit

As NTT DATA Business Solutions, we are more than just a company. We are a team of innovative and passionate people who specialize in creating value-added SAP solutions and guiding our customers on their journey to becoming intelligent businesses. We focus on SAP Consulting, SAP Development, Managed Cloud Services, and Application Management Services (AMS) & Technology.

Our success is based on DIVERSITY, INNOVATION, TRUST, and SUSTAINABILITY - these values are at the heart of our corporate culture.

As part of the global NTT DATA Group, one of the top 5 IT service providers worldwide, we stand for our open and sustainable corporate culture. More than 15,000 employees from 64 nations in over 30 countries show that diversity is integral to our DNA.

People are the key to our success, and we are constantly on the lookout for talented people.

ARE YOU READY TO BREAK NEW GROUND?

Location: Benelux, Germany, France, UK, Turkey, Switzerland, India


Aufgaben

Be part of a team of experts within NTT Data Business Solutions, focusing on Life Sciences projects within a strong international network.

You will be part in one of our country organizations but closely working with our European expert team for Life Sciences in the Global Validation Team. Your role as Validation Officer (f/m/d) includes:

■ Advise and support the (global) project team and our customers in a practical manner about the laws and regulations that apply to each project

■ Manage the process around computer system validation/assurance (CSV/CSA), so that the systems are validated in accordance with laws and regulations, and meet the defined customer requirements

■ Act as a sparring partner for our functional SAP consultants to ensure that a system or process is configured and set up to perform as expected

■ Fulfill the quality assurance function in accordance with other relevant processes, such as the client's quality management system

■ Be responsible for preparing and drafting the validation documentation

Your duties will be:

■ Preparing validation plans

■ Performing risk assessments

■ Preparing and reviewing design specifications, configuration specifications, functional specifications

■ Preparing OQ and PQ test plans and reports

■ Review Validation documentation like test scripts, plans and reports

■ Preparing Validation Summary Reports

■ Deliver GxP trainings to colleagues and customers


Profil

■ Experience in Computer System Validation / Assurance (legal requirements and practical knowledge)

■ Beneficial: life sciences regulation knowledge


■ Thorough knowledge and understanding of business processes and quality management systems in Life Science

■ Ability and willingness to travel and work on projects across Europe

■ English language skills: Level B2 (CEFR) - good reading, writing, speaking. Additional languages (German, French, Spanish) are beneficial

■ Good communication skills


Wir bieten

We have a holistic view of the individual needs of our employees.

■ Flexible working hours and locations: workation, mobile working, part-time models, sabbaticals, etc.

■ Your further development by plan: topic-specific induction, targeted career development based on career models, programs and your own academy

■ SAP Platinum Partnership: strong SAP partnership, large knowledge network, and SAP Learning Hub and certification opportunities.


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