Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.
You'll be responsible for data setups in the eLIMS system to support lab processes. Part of your tasks include reviewing and testing system updates, creating and managing any system related documents, and identifying process improvements
-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 Eurofins with Stability study executions
- eLIMS SKU (Site Key User) role for Eurofins: Update of eLIMS EXT roles stability Access & Securities, SOP’s, training, User Access Management, level 1 & 2 support
- eLIMS Project Management - meetings, planning, documentation (SOP’s, CC’s, …)
- HBO/BSc in the Life Sciences
- 4 – 6 years of working experience in a regulated medical industry (Pharma, Medical Devices, or Diagnostics)
- Experience with LIMS and Quality system is required. Extensive other experience with analytical testing, quality control or IT is preferred.
- cGMPs, applicable regulations (e.g., FDA, ICH Q8, 9, 10), and risk management.
Are you interested and want to apply for this role? Please fill out your application via the apply button below and contact Guilherme Tokunaga at +31 (0) 20 658 98 01 or email@example.com.