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  • Location

    ZUID HOLLAND, Netherlands

  • Job title:

    Technical Specialist (QC)

  • Sector:

  • Job ref:

    44828

  • Startdate:

    2020-08-28

The Organisation 
This organisation is a world-leader in the research & development and production of biotechnology and pharmaceutical products. Their main focus is the production of biologic products and vaccines. For this specific role, you will join the Covid-19 project. 

Role Description 
As a Technical Specialist you will support the required analytical activity and handle quality and compliance related topics, including deviations. CAPA, NPI Gap Assessments and Change Controls. 

Responsibilities 
  • Ensure that assays are executed in a timely manner, cGMP compliant and safe. 
  • Perform GAP analysis, protocols and reports during new product implementation. 
  • Act as a SME for a set of techniques during internal/external meetings. 
  • Create URS's in collaboration with automation specialist and provide input for the new equipment or technologies to NPI Lead. 
  • Acting as lead investigator for Non-Conformances which encompasses conducting the investigation, providing product impact assessments and identifying and defining CAPAs. 
  • Monitor timely closure of medium/high-level investigations and associated CRA’s.
Requirements 
  • Bachelor's Degree in Biology, Biotechnology or similar. 
  • 2-4 years of experience in a GMP environment.
  • Knowledge of testing techniques (chemical separations, sample management, bioassays, AVA/Mycoplasma or biophysical techniques). 
  • Knowledge of CAPAs, non-conformances, change controls. 
  • Excellent communications skills in English. 
Other Information 
For more information please contact Carla Garcia at +31 (0) 20 658 98 01 or c.garcia@sire-search.com

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