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Quality Assurance Manager (m/f) Manufacturing - Germany  

Biontech (company)


Posted on : 09 June 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. 
  • As a part of our lighthouse project IVAC, you will soon take the next critical step with us.
  •  With our company, you will become a worldwide forerunner in the development of a completely new type of immunotherapy against cancer using individualized tumor vaccines. 

Your duties in detail:  
  • Together with your team colleagues (m/f), you will set up and continuously improve a broad-ranging pharmaceutical quality management system for the areas of GCLP, GMP and GCP. 
  • You will also prepare, review, approve and revise regulatory documents (such as SOPs, plans, reports, manufacturing specifications) and assist in preparing PQRs. 
  • Moreover, you will help set up GMP-compliant production and provide quality assurance supervision in routine production in clean rooms. 
  • You will also be responsible for overseeing hygiene and monitoring measures in the production process. 
  • Last but not least, you will provide regulatory supervision in production and storage.   

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 of the relevant rules in the biotechnology/pharmaceutical industry (especially GCLP, GMP and GCP) 
  • Practical experience in quality assurance/quality management or manufacturing 
  • Relevant experience in the routine manufacturing of sterile dosage forms 
  • Reliability, capacity for teamwork and organisational talent. Confident handling of MS Office. Very good English skills, both written and spoken