Computer Systems Validation Analyst - Dreux, France - Norgine
Description
Do you have an interest in Quality and Compliance?Do you have a Degree and a min of 3 years' experience working within validated computer systems in a highly regulated environment?
Would you like to explore a career in Computer Systems Validation?
If so this is an opportunity for a development role where you will be given full support to develop yours skills to become a fully competent CSV analyst.
Sound interesting? Then read on
In this role, you will be responsible for Supporting the Global IT Change Manager in delivering the Global IT validation strategy and approach taking into account the relevant GxP requirements, act as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Risk Management and the project teams in the assessment of proposed new computerized systems or software for GxP impact and where GxP impact is identified provide guidance on the risk based validation approach for the system, working with key stakeholders to achieve business goals.
- Bachelor's degree preferred
- 3+ years' experience of working with validated computer systems in a highly regulated environment.
- Familiarity with a variety of system types such as LIMS, Chromeleon, Weyfringe
- Good understanding of business process
- Knowledge of the data integrity implications of the regulated environment
- Good written and oral communication skills
- Competent user of Microsoft Office
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