Engineering Quality Assurance Specialist

1 week ago

Sligo, Sligo, Ireland beBeeQuality Full time €45,000 - €55,000

Job Overview:

A Quality Assurance and Engineering professional is required to join a leading biopharmaceutical company.

The ideal candidate will be responsible for ensuring engineering activities are carried out in compliance with GMP and site quality engineering standards.

Key Responsibilities:

  • Provide oversight for equipment qualification, utility validation, facility modifications, and engineering change controls.
  • Support the commissioning and qualification (C&Q) 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.

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.

Benefits:

  • Competitive salary and comprehensive benefits package.
  • Opportunities for professional development and career advancement.
  • A supportive and inclusive work environment that values innovation and excellence.

What's Next:

Apply now by clicking the "Apply Now" button or contact Ross Keyes at Sigmar Recruitment. 

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