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Quality Engineer

Reference:RK1570
Location: Cork
Qualification:Degree
Experience:1-2 Years
Job Type:Fixed Term Contract
Salary:Not Disclosed
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May be suitable for: EHS Engineer, Quality Engineer

Quality Engineer
RK1570
Contract – 12 Months
Cork


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties:

  • Team member representing the Quality function supporting projects in with a focus on metals forming processes.
  • Support Quality and Validation activities for product transfers and new product introductions.
  • Responsible for ensuring conformance with current equipment, process, and systems validation regulations.
  • Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.
  • Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis).
  • Determine process inputs and factors for variation where process capability is required.
  • Responsible for reviewing Installation, Operating and Performance Qualification (IQ,OQ, PQ)s.
  • Responsible for conducting Test Method Validations as required
  • Develop/Review pFMEA documentation to support processes as part of Validation process
  • Partner with other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.
  • Conduct investigation, bounding, documentation, review and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate.


Experience and Education:

  • BSc in Engineering or Science
  • 2 years’ experience in a medium to high volume manufacturing environment
  • 1 year in a similar capacity in a regulated industry (i.e. FDA/ISO)
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.




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