Consultant Computerized System Validation

Compliance Services - Singapore

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

-Customer advice as 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
-Customer advice in the conception and implementation of new CSV/CSA requirements from the regulated environment
-Coaching in the field of computerized system validation (CSV), hardware qualification and IT compliance
-Support in business development

Studies

Your profile

-Bachelor’s or master’s degree in the field of Computer Science, Engineering, Pharmaceuticals or in a comparable field
-Very good knowledge of regulatory requirements (FDA, EU, GxP, ISO 13485) and in best practices (GAMP5)
-Several years of professional experience in the field of computerized system validation and /or qualification of hardware as well as in IT compliance topics
-Experienced with software in a production-related environment (especially MES is an advantage)
-Willingness to travel (working from home is also possible)
-Customer-oriented working