Quality Assurance Specialist

3 days ago

Galway, Galway, Ireland beBeeCompliance Full time €80,000 - €150,000

Job Title: Quality Assurance Specialist

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This role is responsible for ensuring the highest standards of quality in all engineering projects and day-to-day operations. The Quality Assurance Specialist acts as a key interface between Engineering and Quality functions to ensure that all systems and processes meet EU GMP standards and are inspection ready.

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The successful candidate will have strong knowledge of validation principles, engineering best practices, and regulatory requirements under GMP. They will be experienced in C&Q documentation, risk-based validation, and change management processes. Familiarity with engineering systems such as CMMS and automated manufacturing equipment is a plus.

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The ideal candidate will have a strong understanding of GMP compliance and quality standards, excellent technical writing skills, and experience of using electronic and physical documentation systems. They will also have excellent attention to detail and significant document review experience.

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Key Responsibilities:

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  • Ensure engineering activities are carried out in compliance with GMP and site quality standards.">
  • 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.">
  • Act as quality representative within engineering-led initiatives (e.g., reliability improvements, energy efficiency upgrades).">
  • Support preparation for regulatory inspections (e.g. HPRA) and internal audits relating to engineering systems and GMP compliance.">
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Required Skills and Qualifications:

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  • Degree in Engineering, Life Sciences, or related technical discipline.">
  • 5+ years experience in a GMP-regulated pharmaceutical, biopharma, or medical device environment.">
  • Strong knowledge of validation principles, engineering best practices, and regulatory requirements under GMP.">
  • Hands-on experience with C&Q documentation, risk-based validation, and change management processes.">
  • Familiarity with engineering systems such as CMMS and automated manufacturing equipment is a plus.">
  • 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.">
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Benefits:

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  • ">
  • Bonus">
  • Pension">
  • Healthcare">
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Keyword: Compliance

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