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QA Specialist

4 months ago

Dublin, Dublin City, Ireland Tandem Project Management Ltd. Full time

Summary:

A QA Specialist is required for a biopharmaceutical company in West Dublin. The successful candidate will support the management of the Supplier Quality program on site. The incumbent will assist in the Supplier approval process and in the management of all Supplier Quality inputs including quality agreements, questionnaires, audits, supplier corrective action reports and supplier notices of change control.

Responsibilities:

  • Support the global supplier and material approval processes including migration of site-based processes to the global process.
  • Support the Quality Agreement management process.
  • Support Supplier Change Notification process to ensure appropriate change control and regulatory updates have been made prior to making changes.
  • Assist in the preparation of inputs to the Supplier Reviews process, including preparation of data for the review, summarizing the results and status of complaints initiated with suppliers to drive improvement.
  • Assist in the monitoring and reporting of supplier performance indicators and contribute to the quality improvement opportunities within the supply chain.
  • Support Continuous Improvement of the Supplier Quality System.
  • Support audits and inspections, as appropriate.
  • Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.

Qualifications & Experience:

  • Relevant degree.
  • Minimum of 1+ years' experience in Quality with medical device, pharmaceutical, or biologics experience.
  • This position requires the individual to understand and follow written SOPs, record all work legibly and in real time; close attention to detail is necessary.
  • A strong customer focus and ability to prioritize and adapt to business needs.
  • Knowledge of applicable international GXP regulations and standards.
  • Experience in Supplier Quality, Material Qualification, Procurement, Quality Assurance, or Auditing is preferred.
  • Experience with Quality Risk Management and Structured Problem-Solving tools is preferred.
  • Experience with Technical Writing is preferred.
  • Experience working with mature supplier quality system is preferred.
  • Experience with SAP and Veeva Vault will be beneficial.

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