NuGenesis Technical SME
Pharma domain knowledge, GxP compliance expertise, NuGenesis SDMS Technical knowledge, Regulatory and audit experience (German Regulatory knowledge mandatory), Knowledge of Agile software validation and validation of computer systems (GAMP 3,4,5),
- Serve as a Technical Subject Matter Expert (SME) for NuGenesis SDMS in GxP environment
- Demonstrate familiarity with Empower functionalities such as methods, reports, and workflows.
- Support and document the system validation lifecycle, including CSV/CSA deliverables.
- Understand SDLC methodologies, including Waterfall and Agile approaches
- Possess a strong understanding of chromatography workflows (HPLC/GC), lab operations, and data integrity standards.
- Collaborate with IT and validation teams to support system installations, upgrades, and validation activities (IQ/OQ/PQ).
- Manage configuration and change control processes in accordance with GxP and data integrity best practices.
- Coordinate with vendors (Waters, Thermo Fisher) and internal IT for support, licensing, and troubleshooting.
- Support data migration and integration with related enterprise systems (LIMS, ELN etc.)
This job is provided by Shine.com
