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Libby O'Donoghue
Life Science

+353 1 507 9254
[email protected]
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Details

Shift Quality Lead (LOA008182)


Reference:A008182 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA RA Engineer

Reporting to the Senior Quality Engineer, Shift Quality Lead duties will include active participation in non-conformance investigations and lot disposition decisions, raising of Quality notifications in response to quality non-conformances and ensuring corrections are completed and confirmed on assembly processes. The Shift Quality lead will provide QA support to the shift manager when required.

Responsibilities:

  • Monitoring the activities of the Quality Control Lab to ensure optimal efficiency and compliance with all regulatory requirements in the QC lab environment.
  • Preparation of relevant work sheets and execution of In Process inspection tests.
  • Ensure required quality testing is carried out; carry out inspections to meet the standard set by the organization Participate in the Change Control Process.
  • Review In process controls, SOP’s, Test Methods, and specifications to ensure Lab inspections are being carried out as per design intent.
  • Analysis of data, quality metrics and trends of in-process inspection data.
  • Liaise with relevant personnel regarding flow of product through QC department and other issues that arise.
  • Preparation, review and approval of technical documentation and perform training as required in the area.


For this role we are looking for candidate with 3+ years of experience in a similar position qualified to a minimum of NFQ Level 6, preferably a Science degree incorporating Quality Assurance. You will have a good knowledge of ISO standards and FDA and would have experience using SAP and Trackwise.