- Ensure all software used for product design and development are kept up to date.
- Ensure compliance of support systems
- Discuss with internal department leaders if their software meets requirements.
- Write, maintain and update Knowledge Management quality documents (SOP's, forms, WI's).
- Perform routine data backups, inspections and quality tests.
- BSc degree in computer science, data science or equivalent.
- Minimum 2 years of IT experience in a highly regulated environment such as Pharma/biotech/medtech industry.
- Minimum 6 months experience with Software Validation
- Knowledge of Software Life Cycles;
- Knowledge of Programming languages.
- Coordinate projects.
- Fluent English (C1/C2 level) is required (spoken and written), French is a plus.
Software verification and validation
- Knowledge of IQ / OQ / PQ
- Specification and execution of V&V protocols
- Analysis and documentation of test scenarios and test cases
- Automation testing platforms