Ensuring Excellence in Quality Assurance

1 week ago

Sligo, Sligo, Ireland beBeeInnovation Full time €45,000 - €55,000
Quality Assurance Specialist

We are seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring that all engineering activities are carried out in compliance with GMP and site quality engineering standards.

The role involves providing oversight for equipment qualification, utility validation, facility modifications, and engineering change controls. You will also support the commissioning and qualification lifecycle, including document review and approval of protocols (IQ/OQ/PQ), risk assessments, and summary reports.

Additionally, you will lead or support investigations related to engineering deviations, non-conformances, and CAPAs ensuring timely closure and root cause identification. You will participate in cross-functional project teams for new equipment introduction, process improvements, and site upgrades, ensuring quality is embedded throughout.

You will act as a quality representative within engineering-led initiatives, such as reliability improvements and energy efficiency upgrades. 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.

  • 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.

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

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