Consultant Computer System Validation (CSV) & IT Quality Management
Computerized Systems engineering, quality, validation Pharmasys founded in 2005 is a growing consultant company for healthcare industry with office in France, Belgium and Switzerland. Our goal is to provide customized consulting services in Engineering, CSV, Quality, Data Integrity and GxP Compliance of automated and computerized systems in the regulated health care sector: pharmaceutical, cosmetics, medical devices. For strengthen our team in Switzerland in supporting proactively our clients , we are looking for a Consultant Computer System Validation (CSV) & IT Quality Management Your responsibilities ? Support quality management and manage CSV activities on mid - size and large complex IT project in GxP environment s ? Support the project team for aligning selected solutions with applicable regulations and client procedures ? Participate in writing, reviewing and approval of CSV documents and procedures ? Support testing, documentation and change management activities as well as risk assessment ? Proactiv ely communicate project status, issues & risks to management Your profile ? University degree in i nformation t echnology or similar ? > 5 years experiences CSV, p roject m anagement , IT quality m anagement ? Experience with IT environments in the healthcare industry (e.g. pharmaceutical industry ) and with applicable regulation s / best practices ( EU Annex 11, 21 CFR Part 11, GAMP 5 ) ? Able to cope with complexity autonomous ly and pro - active ly ? Team player with excellent communication skills ? Ideally, you have experience in one or more of the following areas : ? MES , DCS , ERP, WMS, LIMS ? IT Infrastructure/Architecture ? Fluency in French and English mandat ory (written & spoken), German a plus ? Able to support clients in Switzerland mostly in the French speaking part We offer ? Consultancy services for international clients within an interesting, growing market and with strategically relevant projects ? Professional consultancy environment within a highly motivated team ? Environment with a GxP compliance mindset ? Ownership for shaping and defining new products within our service portfolio ? Promising opportunities for personal development within a growing company Are you interested in taking on this challenging role for our company and to develop your career to the next level? We are looking forward to your comprehensive application, including CV and testimonials via eMail to email@example.com - www.pharmasys.ch Reference: CM - CH 16/00 9 .