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 monoclonal antibodies to protect people worldwide from immunological diseases.
As a Deviation lead, you'll be responsible leading the deviation investigations of any deviation that occurs in the manufacturing facility. You'll also be responsible for investigations, including Product Impact Assessments, Root Cause Analysis, and Corrective Actions.
- Responsible for follow up, and ensuring compliant documentation and timely completion;
- Ensuring that relevant corrections and/or improvements on production processes and systems are made within the VF;
- Monitor progress and KPI for this process
- Act as a Subject Matter Expert on Deviations during inspections and audits
- BSc/MSc in biotechnology, biochmistry, biomedicine, process technology (or equivalent education)
- Min 2-4 years relevant work experience in a biotechnology or biopharmaceutical industry environment. Technical background (TU) is also okay.
- Previous experience as a deviation lead in a cGMP environment is required
- A preference for experience with Trackwise QEM
For more information please contact Guilherme Tokunaga at firstname.lastname@example.org or +31 (0) 20 658 98 01.