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Senior QA/QC Officer Leiden Netherlands,  

BATAVIA Biosciences (company)


Posted on : 26 March 2017

Project Description


Description:
  • We are looking for an experienced Sr. QA Officer for our Headquarters , The Netherlands. 
  • As a senior QA/QC officer you will support in all GMP aspects related to production and testing of biological for clinical trials. 
  • Additionally, you will lead process improvement projects within QC and QA (e.g. sample management, risk management, change management). 
  • The activities will include, but are not limited to,
    •  monitoring of the GMP system throughout the manufacturing process,
    •  investigating and troubleshooting any potential issues that arise, 
    • reviewing and advising on assay validation protocols/reports, 
    • advising on the content of process related documentation (such as bill of testing, master batch records, etc.), 
    • assessing changes, reviewing and/or performing root cause analysis, 
    • defining and implementing preventive/corrective actions, and providing support during customer audits. 
  • Additionally, you will be the first QA/QC point of contact for any GMP related questions. 
  • You will join a stimulating group of international researchers in a very collaborative environment. 
  • This position reports to the Director Quality Assurance.  


Requirements:
  • Bachelor or master degree in life science, biotechnology, biochemical engineering or related subject; 
  • At least five years  experience at QA/QC in biotechnology or biopharmaceutical industry, preferably in production of early clinical trial material; 
  • Experience with and understanding of GMP regulations; 
  • Good command of the English and Dutch language (written and spoken).  



In the interviews it will be clear that: 
  • You are enthusiastic and comfortable in a dynamic environment. 
  • You are able to think analytical, innovative and pragmatic. 
  • You can work both in a team and individually. 
  • You communicate clearly at all levels;
  •  you can get your thoughts, ideas and knowledge across in a helpful and clear way. 
  • Your planning and organization skills allow you to have an overview of the necessary work and you are able to meet deadlines. 

Locations

Leiden The Netherlands

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