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Quality Assurance Manager (m/f) Quality Control Mainz Germany,  

Biontech (company)


Posted on : 09 June 2017

Project Description

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. 
  • 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, testing procedures) and assist in preparing PQRs. 
  • Moreover, you will supervise quality assurance in routine analytics in the field of GMP, including ambient monitoring. 
  • In regulatory matters, you will also serve as a contact partner for method transferring and validation. 
  • Processing OOS cases 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 of the relevant rules in the biotechnology/pharmaceutical industry (especially GCLP, GMP and GCP) 
  • Practical experience in quality assurance/quality management or quality control 
  • Relevant experience in the routine analytics of sterile dosage forms 
  • Reliability, capacity for teamwork and organisational talent. Confident handling of MS Office. Very good English skills, both written and spoken. Experience in laboratory information management systems (LIMS) is advantageous   

Locations

Mainz

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