Principal Quality Engineer Position

2 weeks ago

Sligo, Sligo, Ireland beBeeCompliance Full time €45,000 - €55,000
Senior Engineering Compliance Specialist

This position involves ensuring that engineering activities are conducted in accordance with Good Manufacturing Practice (GMP) and site quality engineering standards, thereby maintaining compliance.

  • The incumbent will be responsible for overseeing equipment qualification, utility validation, facility modifications, and engineering change controls to ensure seamless integration of new systems and processes.
  • Support the commissioning and qualification lifecycle by reviewing and approving protocols (IQ/OQ/PQ), risk assessments, and summary reports.
  • Lead or support investigations related to engineering deviations, non-conformances, and Corrective Action Preventative Actions (CAPAs) to facilitate timely closure and root cause identification.
  • Act as a quality representative within engineering-led initiatives, fostering collaboration and effective communication between teams.

Requirements:

  • Strong understanding of QA expectations (deviations, CAPAs, change control), GMP, and GDP principles.
  • Proven ability to work independently while effectively contributing to team environment, utilizing initiative and problem-solving skills.
  • Experience working in a matrix role bridging Engineering and Quality departments, promoting cross-functional collaboration.
What's On Offer

Competitive compensation package, comprehensive benefits, opportunities for professional development, career advancement, and a supportive and inclusive work environment that values innovation and excellence.

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