We are looking for a Senior ELN / SDMS Consultant with strong hands‑on experience in NuGenesis SDMS to support a global life sciences client in a regulated (GxP) environment.
This role focuses on system validation, production support, and compliance, working closely with IT, Business, and Quality teams to ensure data integrity and regulatory readiness.
What you will do
- Validate NuGenesis SDMS in line with GxP, FDA 21 CFR Part 11, and EU Annex 11 requirements
- Configure and maintain File Captures in NuGenesis based on client needs
- Provide technical support and troubleshooting to ensure system stability
- Handle Incidents and support L2/L3 issues through Problem Management
- Support audits and inspections by regulatory authorities and internal QA teams
- Participate in implementation, migration, and deployment activities
- Assist with IQ / OQ / PQ validation protocols and documentation
- Collaborate with IT, Business, and Quality stakeholders to maintain system integrity