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  • Location

    Leiden, Gemeente Leiden, South Holland

  • Job title:

    QC Technical Specialist Bioassays

  • Sector:

  • Job ref:

    46487

  • Start Date:

    2021-07-15

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 and vaccines to protect people worldwide from immunological diseases

Role Description 
As a Technical Specialist you will join the Bioassays team within the QC department, responsible for the testing of end products. You will handle quality and compliance related issues (high-level deviations, CAPAs, assessments) to maintain cGMP compliance. 

Responsibilities 

1. Deviation Management
- Investigate local/global Non-Conformances, provide product impact assessments and defining CAPAs.
- Monitor timely closure of medium/high-level investigations and associated CAPA’s.
- Supporting and advising other lead investigators from external and internal QC departments.

2. Lab Execution
- Coordinate activities related to NPI introductions.
- Ensuring that assays can technically be executed in an efficient and cGMP compliant manner. 
- Crafting URSs for equipment 
- Gathering and analysis of assay performance data 
- Lead and drive continuous improvement


Requirements 
- BSc or MSc in Life Sciences 
- Min. 2 years of experience with Bioassays (ELISA, cell cultures, PCR) 
- Min. 2 years of experience in a GMP lab 
- Excellent communications 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