Banner Image
  • Location

    Leiden, Gemeente Leiden, South Holland

  • Job title:

    GMP Specialist

  • Sector:

  • Job ref:

    46581

  • Start Date:

    2021-08-05

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 GMP Specialist you will be responsible for leading deviations investigations of any deviation occurred in the vaccine manufacturing facility. 

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 system;
- Monitor progress and KPI for this process
- Act as an SME on Deviations during inspections and audits;
- Coordinate deviations training and training-syllabi; 
- Leading process excellence activities to continuously improve the work as well as personal skills.


Requirements 
- Min. BSc in biotechnology, biochemistry, biomedicine, process technology or similar.
- Min. 4 years of experience within the biopharmaceutical industry in a similar role.
- Excellent communication skills in English. 


Other Information 
For more information please contact Carla Garcia at c.garcia@sire-search.com or +31 (0) 20 658 98 01. 

Contact us

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804