SIRE Life Sciences® is a recruitment and executive search consultancy, dedicated exclusively to the European Life Science industry. SIRE Life Sciences® provides a Complete Life Science Cycle Search Solution to both Life Science Professionals and Life Science Employers operating in the European Life Science Sector. We provide a tailor made European wide service for both permanent and freelance solutions, specialized in delivering to the world's leading Life Science institutions.
As the IT Systems Consultant you will act as the 3rd line support specialist for several IT Business Applications on a local and global scale. You will be responsible for the implementation, improvement and compliancy of several applications in regulated environments (FDA / GAMP). In order to do so, you will work within globally dispersed project teams for the international projects and act as project lead for several local projects.
Since this role requires you to work within strongly regulated environments, I am looking for somebody who has previous experience in the Life Sciences industry or similar (FDA / 21 CFR Part 11 / GAMP).
3rd line support role for several Business Applications
Project Management activities within international project environments
Act as a liaison between several end-users, clients and the business
Deployment of hardware and software in regulation environments (CSV / GAMP)
Facilitate multidisciplinary team meetings to meet business requirements
Create synergy for several business units by applying new business applications
Implementation of several communication applications on a local and global scale
Process Mapping for globally dispersed project teams
Continuous Improvement of business applications
Compliancy of Project Documentation and several IT Systems
Act as representative during FDA / Regulatory audits
Training of end-users
10 years’ experience with Information Systems in the Life Sciences industry
10 years’ experience with implementation of IT solutions
10 years’ experience with Microsoft OS and Server environments (Active Directory, Windows, Group Policies)
Experience in Automation and IT Systems
Project Management experience and previous experience with MS Project (or similar)
Validation experience (CSV / GAMP5)
Experience with the development of SOPs / Installation Protocols / Operational Protocols
Fluency in English and preferably in Dutch
Good Time Management skills and be able to work under pressure
Agile / Rup experience is a strong plus
Change Management experience in complex and regulated environments is a strong plus
FDA experience (21 CFR Part 11 or similar) is a strong plus
Previous experience with MES systems is a strong plus
Serialisation experience is a strong plus
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