Banner Image
  • Location

    Leiden

  • Job title:

    Deviations Lead (Pharma)

  • Sector:

  • Job ref:

    47028

  • Start Date:

    2021-11-15

The Company 
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.

Role Description 
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.

Responsibilities 

- Lead deviation investigation in documenting product impact analysis and root cause investigation, including CAPA records
- 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


Requirements 
- 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.


Other Information 
For more information please contact Ece Karakurt at e.karakurt@sire-search.com or +31 (0) 20 658 98 01.