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Quality Intern - Ireland  

Company managed [?] Still accepting applications

Posted on : 10 July 2017

Project Description

 

 

 Intern – Quality 

 

 

Reports to:

Manager, Quality System and Compliance

Location:

Dublin, Ireland

 

Position Summary:

Operating within the Quality Systems team to support the administration of an appointed Quality Systems as required. Current activities require that the QMS element to be supported is Quality Department document and vendor management.

 

Principal Responsibilities

  • Supports the work of the Quality Systems and Compliance team by the coordination and optimization of Quality Management Records relating to Deviation, Change  and CAPA
  • Supports the business through coordination of day to day operations and change management relating to Quality e-Systems such as TrackWise
  • Generation, development and communication of Site Quality Metrics and measurements to support the on-going development of site compliance.
  • Leads or participates in internal audits of APIT to assess compliance to international GMP requirements and Alexion Quality standards and ensures timely issuance of internal audit reports and follow-up on responses and corrective actions. Tracks completion of activities from scheduling through to audit closure.
  • Assist with firstDOC administration as required.
  • Assist with Document Periodic Review of key Quality documents
  • Assist with archival of GxP Records.
  • Support the execution of Vendor Management improvement projects

 

 

Dublin, Ireland
 

 

Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.