Expert in Regulatory Compliance

3 days ago

Sligo, Sligo, Ireland beBeeQuality Full time €60,000 - €80,000

Job Title: Quality Assurance Specialist

Description:

The successful candidate will provide oversight for the engineering lifecycle, ensuring compliance with regulatory requirements and site standards.

Key Responsibilities:

  • Ensure that all engineering activities are carried out in accordance with established protocols, policies, and procedures.
  • Provide technical guidance and support to cross-functional project teams for new equipment introduction, process improvements, and site upgrades.
  • Act as quality representative within engineering-led initiatives, ensuring that quality is embedded throughout all phases of project development and implementation.
  • Support the commissioning and qualification (C&Q) lifecycle, including document review and approval of protocols, 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 training programs to enhance knowledge and skills in areas such as validation principles, engineering best practices, and regulatory requirements.
  • Maintain and improve engineering quality processes, such as document control, calibration systems, and preventative maintenance compliance.

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, BMS, and automated manufacturing equipment.

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