Beschreibung
Edelway is a Swiss consultancy active in the field of Pharma and IT.
We are actively looking for a Senior Computer System Validation(CSV) consultant to join our global pharmaceutical client in Neuchâtel, Switzerland.
The Role:
* You'll support quality management and CSV activities on IT projects and programs.
* This will include conducting quality reviews of IT systems and processes, writing, reviewing and approving the required documentation and ensuring compliance with regulations, standards and clients' quality management systems.
* You will review technical writing; support PowerPoint presentation etc.
* With a keen eye for details, you'll identify errors or deficiencies in IT systems and processes and drive their continuous improvement.
* Writing, reviewing and implementing IT procedures, processes and working instructions will also be part of your role.
* You'll support testing, documentation and change management activities as well as risk assessments and risk mitigations.
Your profile:
* Educational background in IT, Business, Natural Sciences or Engineering
* At least 4 years of hands-on work experiences in quality management and CSV or another quality assurance area within the pharmaceutical industry
* Some experience Computer System Validation activities on GxP IT projects/systems
* Good knowledge of Microsoft Office tools (Word, Visio, Project, Excel, PowerPoint, SharePoint)
* Experiences in working on IT projects and programs within multicultural, global or virtual project teams
* Good business communication and presentation skills, fluency in English
If this sounds like your next challenge, send me your CV at (see below)
Keywords: CSV, validation, IT, system, GxP, compliance, regulations