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QAV CSV Engineer

  1. Dublin
  1. Contract
Competitive
24112
  1. Life Sciences
Date Posted07 Jan 2020
QA CSV Engineer required to join a global biotech company in Dublin for an initial 12 month contract to start as soon as possible. 

One of the main job functions will be to provide QA support for the approval of Automation Change Controls as the various systems. 

On a high level we are looking for someone to support the CSV QA team on site dealing with the various systems that they will be installing and utilising. 

Role and Responsibilities:
  • Automation Change Control participation, review and approval.
  • Providing compliance oversite @ PAS SFAT’s.
  • Qualification testing compliance review and approvals. Including RTM’s and Summary Reports.
  • Performing leveraging assessments.
  • Providing compliance oversite for lifecycle documentation, i.e DS, FS, HDS etc.
  • Responsible for coordinating the paper-based documentation under compliant processes.
  • Ensure filing and maintaining all test records under the GMP regulations and standards.
  • Testing documents quality review.
  • Incident Log Sheets review and approvals.
  • Design Documents review and approvals.
  • Updating trackers for documents review.
  • Support problem solving for testing and ILSs documentation issues.
This is a fast moving and exciting project. If you would like further information, please apply.

The candidate must have the rights to work in the location stated in the job advert.

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