Do you have experience in IT and have a background in Life Science? We are looking for a technical expert in the field of (e)LIMS data management to support different labs with the integration of new equipment and workflow processes
In this position you will support the deployment and maintenance of the digitalization/automation project for different labs. The laboratory mission is to increase lab reliability through automation of processes and reduction in manual transcription of data, improved electronic control and data capture, delivering Data Integrity and Efficiency value using global lab systems and interfaces.
- Build & Maintenance of DS & DP Specifications and Stability studies & Work items to support Stability testing
- Maintain CBER automated reports
- Build & Maintenance of Workitems, Super sample templates to support IPC's and release testing
- Support clients with Stability study executions
- eLIMS SKU (Site Key User) role: Update of eLIMS EXT roles stability Access & Securities, SOP's, training, User Access Management, level 1 & 2 support
- Bachelor's degree or equivalent education is required
- A minimum of 2 years of working experience in a regulated medical industry (Pharmaceutical, Medical Devices, or Diagnostics) with knowledge and experience with LIMS and Quality system is required.
- Ability to manage multiple issues, organize activities, prioritize, and escalate to management when appropriate.
- Broad knowledge and experience with cGMPs, applicable regulations (e.g., FDA, ICH Q8, 9, 10), and risk management.
- Demonstrated strong written and verbal communication skills
- Contract: 1 year via Oxford, realistic long- term perspective
- Salary: €3000- €4000 gross monthly based on a full-time position
- Holidays: 25
- Working hours: full-time, 32 hours discussable
- Region: Leiden
Vacancy number: 16726