The CSV Analyst will support GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems
Job Summary
The CSV Analyst will support GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems.
Key responsibilities include evaluating proposed new computerized systems, assisting in the development of validation deliverables, and managing formal testing of computerized systems.
Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions, offering a minimum of 2000€ gross monthly wage plus an annual global incentive plan-bonus and other benefits.
Matching Summary
The CSV Analyst will support GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems.
Salary
Base: minimum 2000€ / monthly; Bonus/Equity: annual global incentive plan-bonus; Benefits: other benefits in compliance with social benefit program
Skills & Requirements
Must-have
GxP regulations and best practice
risk-based validation approach
validation deliverables development
computerized systems validation lifecycle
GxP impacting projects support
Nice-to-have
adapt to new situations
influence and negotiate
constructively challenge
high concentration of work
conscientious and highly committed
Key Requirements
Bachelor's degree in computer science, engineering, life science or related field
2 years experience with CSV validation lifecycle management
2+ years pharmaceutical manufacturing or Medical Device industry experience
Excellent understanding of industry regulations, standards, and guidelines