QA Compliance Specialist: Change Control & Quality Systems

Regeneron; Limerick; On-site; EUR 46,200 - 75,400; Full time

Job summary

Regeneron in Raheen, Limerick, is seeking a Quality Systems specialist to support Change Control administration, review, and lifecycle oversight. You will ensure compliance with cGMP and regulatory expectations while coordinating with Manufacturing, QA, Engineering, Validation, and Supply Chain to implement approved changes.

The role emphasizes governance, timely action on open records, CAPA investigations, and developing training on Change Control and Quality System processes.

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• Requires 3-5+ years of experience in pharma/biotech or other regulated industries.
• Relevant experience may substitute for formal education.

Responsibilities

• Supporting administration, review, and coordination of Change Control records.
• Providing quality oversight of Change Control activities through lifecycle.
• Reviewing and approving Quality System documentation (Change Control, CAPA, Deviations, risk assessments, SOPs).
• Collaborating with Manufacturing, Quality Control, Engineering, Validation, Supply Chain and others.
• Ensuring Change Controls are categorized, assessed for impact, and progressed per timelines.
• Supporting governance activities, monitoring open records, escalating risks, driving actions.
• Assisting in generation, monitoring, and trending of Quality System metrics.
• Participating in investigations and CAPA actions; developing training on Change Control.

Skills

Change Control

Deviations

CAPA

Audit Management

Risk Management

Documentation

Education

Bachelor's degree in Science or Engineering or Pharmacy or Biotechnology

Job description

Regeneron in Raheen, Limerick, is seeking a Quality Systems specialist to support Change Control administration, review, and lifecycle oversight. You will ensure compliance with cGMP and regulatory expectations while coordinating with Manufacturing, QA, Engineering, Validation, and Supply Chain to implement approved changes.

The role emphasizes governance, timely action on open records, CAPA investigations, and developing training on Change Control and Quality System processes.