CSV Analyst 12 Month FTC

We are seeking a CSV Analyst to join our team at Norgine. The ideal candidate will have a Bachelor's degree and experience in validation and qualification of complex computer systems. They will be responsible for ensuring that Norgine's IT Quality Management System meets regulatory requirements and will work closely with other team members and consultants to identify and close gaps.

Requirements

• Assist the CSV/Lead Process Analyst in continued improvement and delivery of the Global IT validation strategy and approach
• Support the continuous improvement of appropriate procedures to be used in validating computerized systems
• Review proposed changes to validated computerized systems and identify the validation requirements necessary to maintain the system's validation status
• Support project teams in defining the appropriate level of validation required based on a risk assessment
• Support formal testing of computerized systems ensuring that test plans, test scripts and test results comply with the regulatory requirements based on system risk