Quality Assurance Specialist

2 weeks ago

Sligo, Sligo, Ireland beBeeQuality Full time €64,000 - €88,000
Job Title: Quality Assurance Specialist

Job Description:

We are seeking a Quality Assurance Specialist to join our team. The successful candidate will play a key role in ensuring the highest level of quality in all engineering projects and day-to-day operations.

Key Responsibilities:

  • Ensure that engineering activities are carried out in compliance with GMP and site quality standards, identifying areas for improvement and implementing corrective actions as necessary.
  • Provide oversight for equipment qualification, utility validation, facility modifications, and engineering change controls, maintaining accurate records and reports.
  • Support the commissioning and qualification (C&Q) lifecycle, including document review and approval of protocols (IQ/OQ/PQ), risk assessments, and summary reports, ensuring timely completion and effective communication with stakeholders.
  • Lead or support investigations related to engineering deviations, non-conformances, and CAPAs, conducting root cause analyses and developing corrective action plans to prevent recurrence.
  • Participate in cross-functional project teams for new equipment introduction, process improvements, and site upgrades, collaborating with colleagues to ensure quality is embedded throughout the project lifecycle.
  • Act as quality representative within engineering-led initiatives, providing expertise and guidance on quality-related matters and ensuring alignment with company standards.
  • Support preparation for regulatory inspections (e.g. HPRA) and internal audits relating to engineering systems and GMP compliance, maintaining accurate records and reports.
  • Maintain and improve engineering quality processes, such as document control, calibration systems, and preventative maintenance compliance, staying up-to-date with industry best practices and regulatory requirements.

Requirements:

  • Degree in Engineering, Life Sciences, or a 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 (eMaint), BMS (IQ vision), and automated manufacturing equipment is a plus.

Benefits:

As a Quality Assurance Specialist, you will enjoy a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.

What We Offer:

A dynamic work environment, collaborative team culture, and recognition for outstanding performance and contributions to the organization's success.

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