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  • Location

    Leiden, Gemeente Leiden, South Holland

  • Job title:

    GMP Documentation Specialist

  • Sector:

  • Job ref:

    46602

  • Start Date:

    2021-08-10

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 Documentation Specialist you will act as the first point of contact within the production teams for questions related to documentation and procedures. As your main goal, you will work on the maintenance and improvement of batch documentation in order to enable electronic batch record introduction.


Responsibilities 
- First departmental contact for questions about batch documentation and procedures
- Initiating and handling of compliance records (Change Control, non-conformances and CAPA records) including root cause analysis
- Leading project with end-users to improve process documentation
- Working accurately and detecting opportunities for improvement with proper follow up, both on compliance work processes as well as personal development


Requirements 
- HBO/BSc with 3 years of proven experience in pharmaceutical/biotechnology
- Experience with change controls, non-conformances and CAPA records
- Experience with cGMP and EHSS standards is required
- Experience with Veeva truVault is highly advantageous 


Other Information 
For more information please contact Ece karakurt at e.karakurt@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