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Quality Assurance Manager (m/f) Computer System Validation - Germany  

Biontech (company)


Posted on : 15 May 2017

Project Description

  •  Everyone achieves greatness at our company.
  • As one of the most rapidly growing biotechnology companies in Europe, we’re working on revolutionary approaches in the fight against cancer and other diseases. 
  • Over 500 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future. 
  • You too can become a pioneer!  Here, you’ll achieve greatness. 
  • At our company  you will be responsible for developing and maintaining a dynamic QA system in accordance with national and international standards.

Your duties in detail:  
  • It won’t be long before you are supporting computer system validation projects. 
  • This includes reviewing computer system validation documents with regards to their regulatory conformity. 
  • You will also process and evaluate change requests relating to computer-based systems. 
  • Performing self-inspections and supplier audits (concerning computer-based systems) also falls within your scope of duties.   

What you have to offer.  
  • Degree in natural sciences or completed vocational training as a biology lab technician, BTA, MTA, PTA, CTA (m/f) or equivalent qualification 
  • In-depth knowledge and practical experience in quality assurance/quality management and the relevant rules in the biotechnology/pharmaceutical industry 
  • Experience in the field of software validation 
  • Reliability, capacity for teamwork, organisational talent and a technical understanding 
  • Very good English skills, both written and spoken