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  • Functie titel:

    GMP Change Controls Specialist (Pharma)

  • Sector:

    Biotechnology

  • Job ref:

    46113

  • Start datum:

    2021-05-01

The Company 
Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of biologics to protect people worldwide from immunological diseases.

Role Description
As a  GMP Change Controls Specialist you'll be responsible for the progress of GMP Change Controls + supporting quality deviations and CAPAs.

Responsibilities 
  • Writing change controls for the GMP/ EHS systems and responsible for follow up and timely documentation and completion;
  • Keeping GMP documentation up-to-date;
  • Support in improvements on production processes and systems within the Vaccine Facility 
  • Support lead deviation investigation in documenting product impact analysis and root cause investigation and timely follow up (including CPA records) and completion;

Requirements 
  • BSc in a relevant Life Sciences degree
  • 2 years relevant work experience in a biotechnology or biopharmaceutical industry environment. Technical background (TU) is also okay.
  • Experience in Quality Systems, specifically Change Control
  • Working knowledge with cGMP standards is required.
  • A preference for experience with Trackwise QEM, Docspace or similar automated systems
Other Information 
For more information please contact Ece Karakurt at e.karakurt@sire-search.com or +31 (0) 20 658 98 01. 
Neem contact op

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