Compliance Consultant / Computer System Validation

Compliance Services - Kosice

About Arcondis

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,

information technology, and digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

Open Position

Mission

Tasks and responsibilities

Advice clients as a project manager or project employee in the conception and implementation of software validation projects, hardware qualification projects and IT compliance projects in a regulated environment
- Development, production and logistics for the pharmaceutical and medical technology industry
Implementation of IT compliance audits in the client environment
Client advice on the conception and implementation of new IT compliance requirements from the regulated environment as well as the conception and implementation of IT quality management systems
Conception and implementation of IT quality management systems
Training & coaching in the field of computer system validation (CSV), hardware qualification and IT compliance
Support in the acquisition of new clients and projects

Studies

Your profile

Academic training in the field of business informatics, engineering, pharmaceuticals or a comparable subject
Experience in performing multiple validations and / or hardware qualifications as a project member or project manager
SAP R3 / SAP Hana experience is an advantage
Very good knowledge of the underlying regulatory requirements (FDA, EU, GxP, ISO 13485) and best practices (GAMP5)
At least 3 years of professional experience in the field of computer system validation and / or qualification of hardware as well as in IT compliance topics
Experience in setting up IT quality management systems in the pharmaceutical and / or medical technology field
Fluent written and spoken German and English
Traveling
Enjoyment of client service