Our client is a 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.
As a Documentation Specialist you will ensure that the documentation related to the Covid-19 clinical trials materials production.
Preparations, Cell culture/ Upstream processing, Downstream processing, and the Operations Support Team. The teams are responsible for their cGMP status by maintaining the documentation system, reporting quality issues, and performing the resulting corrective actions, master batch documentation, training, and inspection readiness.
- • Responsible for document adjustments to align with the new standard to avoid issues in the production process.
- • Ensure the continuation of the production processes for cGMP clinical trial material.
- • Connect with specialists and partners inside and outside the department to assure the correctness of the documentation.
- • Lead a project team to update the documentation according to standard as well as update the documentation.
- • Review batch documentation.
- • Minimal a BSc degree with 3 years of proven experience in pharmaceutical/biotechnology companies.
- • Experience in cell culture (USP), virus propagation, and/or downstream processing (DSP).
- • Proven experience in project leadership.
- • Experience with change controls, non-conformances, and cGMP documentation changes.
- • Experience with cGMP and EHSS standards is required.
- • Lean green belt certification is a plus.
For more information please contact Carla Garcia at +31 (0) 20 658 98 01 or email@example.com.