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QA Generalist - Documentation

  • Salary: Negotiable
  • Job type: Contract
  • Location: Dublin
  • Sector: Quality & Compliance
  • Date posted: 04/09/2017
  • Job reference: J373477A

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QA Generalist/Documentation Specialist

Our client is seeking to recruit a Quality Assurance Generalist/Doc Control to join their QA Team. Reporting to the QA Process Team Lead. The role will be an initial 12 month contract.

Key responsibilities:

  • Review and approval of Cleaning Batch Documentation and Manufacturing in accordance to
  • Participate with the internal audit team
  • Generation of certificate of analysis
  • Final deposition of material
  • Execution of QA activities in a timely manner
  • Tracking that deviations are raised and closed in a timely manner
  • Ensuring that all repeat deviations are assessed to identify if the CAPAs put in place for the previous event were appropriate
  • Prepare and update training documents, courses and assessments
  • Use critical analysis and scientific reasoning to resolve issues
  • Responsible for maintaining the document management system
  • Maintaining the document database

Required Experience/Qualifications:

  • Technical qualification in Science or Engineering or qualification relative to the position
  • A minimum of 1 years' experience within a regulated environment - preferably pharmaceutical or medical device.
  • Excellent PC skills
  • Proven ability to work to deadlines and working in a team environment

For more information on the role please contact Darragh Sexton on or 01-6455250.