QA Systems Specialist

Contract
Dublin, Ireland
Posted 1 year ago

Supporting the Quality Systems team on site, the QA Systems Specialist role will be primarily involved in supporting Quality Systems activities on site. All relevant activities on site are conducted in compliance with cGMP and site Standards

 

 

Responsibilities

 

  • The QA Systems Specialist will be responsible for supporting Site Quality Management Systems with responsibilities which may include:
  • Supplier Quality Management activities
  • Change Management
  • Document management
  • Quality Approval of documents
  • Quality Oversight on pest control
  • Supporting Quality Council
  • Inspection readiness activities
  • This role will also support transition activities and integration to new quality management systems as required

 

Qualifications & Education

 

  • Experience in Quality Systems in Pharma/Biopharma industry
  • In depth knowledge of GMPs and Good Documentation and Data Practices
  • Experience with reviewing and approving documents such as Procedures, Change controls and  Investigations
  • Ability to work independently and effectively in a fast-paced environment delivering to a high quality standard.
  • Demonstrated knowledge of Quality Management Systems tools, continuous improvement methodologies and in-depth understanding of site processes.
  • Strong technical aptitude (ability to read & comprehend technical documentation and execute procedures)
  • Liaise with internal partners to drive deliverables to completion
  • Experience in a similar role in Pharma, with the following activities:
  • Supplier Quality Management activities
  • Change Management/ Change Control
  • Document management
  • Quality Approval of documents
  • Quality Oversight on pest control
  • Supporting Quality Council
  • Required: Science or Engineering Degree
  • Desirable: Masters in appropriate discipline

 

To apply contact Martin Lynch on 087-344 3581.

 

Email CVs to mlynch@mile.ie

Job Features

Job CategoryQA

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