Quality Process Optimization Specialist

3 days ago

Sligo, Sligo, Ireland beBeeQuality Full time €60,000 - €90,000

Optimize quality processes to deliver innovative solutions. A dynamic and collaborative environment values innovation and excellence.

About the Job
  • Ensure engineering activities adhere to GMP and site quality engineering standards.
  • Provide oversight for equipment qualification, utility validation, facility modifications, and engineering change controls.
  • Support commissioning and qualification lifecycle, including document review and approval of protocols (IQ/OQ/PQ), risk assessments, and summary reports.
  • Lead or support investigations related to engineering deviations, non-conformances, and CAPAs ensuring timely closure and root cause identification.
  • Participate in cross-functional project teams for new equipment introduction, process improvements, and site upgrades, ensuring quality is embedded throughout.
  • Act as quality representative within engineering-led initiatives.
  • Support preparation for regulatory inspections and internal audits relating to engineering systems and GMP compliance.
  • Maintain and improve engineering quality processes, such as document control, calibration systems, and preventative maintenance compliance.
Requirements
  • Strong understanding of QA expectations (deviations, CAPAs, change control), GMP, and GDP.
  • Proven ability to work effectively on their own initiative as well as effectively contributing to the team environment.
  • Experience working in a matrix role bridging Engineering and Quality departments.
  • Knowledge of ISPE Baseline Guides, GAMP 5, and data integrity best practices.
  • Six Sigma / Lean certification is advantageous.
What's Next
  • Competitive salaries and comprehensive benefits packages are offered.
  • Opportunities for professional development and career advancement exist.
  • A supportive and inclusive work environment that values innovation and excellence.

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