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QA Leader

  • Job type: Permanent
  • Location: Düsseldorf
  • Salary: Competitive
  • Job reference: QA Leader
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 28/07/2017
The Company




QA Leader:


 


My client is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. In 2017, they are rapidly expanding and their current site in Ireland has the potential to grow into a more global and senior position within the next few years. 


 


The Role




QA Leader:

Management and organization of the quality assurance system / quality management. Ensuring regulatory standards (eg GMP). Ensuring quality standards in the context of pharmaceutical development projects (cell line development, process development, upstream processing, analytical development). Contact for GLP / GCP / GMP questions at the site. Introduction of the electronic document management system. Mainly responsible for the introduction of data integrity procedures (including documentation, electronic data storage and archiving). Administration and further development of the pre-assignment documents (preparation / revision of quality management manual, site master file, SOPs, operating instructions etc.). Management of the electronic document management system.


 


 


Job Requirements


  • Established Quality Assurance Management background
  • GMP & GLP experience essential
  • Experience with FDA & European regulatory requirements, guidelines, and expectations
  • Experience building a team
  • BSc or MSc in Pharmaceuticals/Biochemistry/Biomedical
  • Fluent English essential
 


If this a position you are interested, please submit a copy of your most up-to-date CV on Microsoft Word format to;


apply.a33ho1gh2wa@epmscientific.aptrack.co.uk


Or Call;




+0044 203 758 8784



Nicky Walsh




Head of Quality Management for EPM Scientific, Ireland


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