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  • Location

    Zuid-Holland , Netherlands

  • Job title:

    QA Documentation Expert

  • Sector:

    Biotechnology

  • Job ref:

    45937

  • Start Date:

    2021-03-31


The Company 
Our client is a professional Pharmaceutical organisation, based in Netherlands. They focus on the discovery, development, manufacturing and marketing of biologic products to protect people worldwide from a range of diseases. Together with another 150 locations world wide they are trying to achieve the best possible results for their health.

Role Description 
As a QA Officer you will be responsible for the batch documentation review of incoming raw materials and subsequent release. 

Responsibilities 
  • - Review of paper and electronic Batch Records on completeness, clarity, and GMP compliance;
  • - Review of raw material related documentation and release of raw materials
  • - Provide advice to requesting departments regarding GMP aspects;
  • - Review and approve QA controlled documentation (SOP’s, Batch Records, work instructions)
  • - Assessing change requests on consistency, relevance, GMP compliance, and clarity
  • - Review and Preparation of batch release documentation;
  • - Support the department in continuous improvement activities

Requirements 
  • - BSc/HBO (or equivalent) in bioscience, chemistry, pharmacy or equivalent;
  • - Up to date knowledge of current GMP regulations;
  • - Experience in pharmaceutical or related industry (QA, QC, Production Operations or supporting functions).

Other Information 
For more information please contact Guilherme Tokunaga at g.tokunaga@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
+31 (0) 20 658 9804