Quality Assurance Specialist

Role overview

The Quality Assurance Specialist, Deviations is responsible for providing QA leadership and technical expertise across deviations, investigations, CAPAs, and change controls. In this onsite role based in Dublin, you will partner with Manufacturing, Engineering, Validation, Quality Control, and Supply Chain to ensure investigations are handled thoroughly, on time, and in line with GMP, regulatory expectations, and company quality standards.

Key responsibilities

• Oversee deviations, investigations, CAPAs, and change controls from a quality assurance perspective, with a focus on prompt and compliant completion.
• Evaluate and approve quality documentation, making sure the issue is properly defined, root causes are well supported, risks are assessed, and actions are appropriate.
• Act as QA representative in Deviation Review Boards, Change Control Boards, and similar cross-functional meetings.
• Assist with complex investigations and provide practical quality input on compliance-related and operational matters.
• Track trends across the quality system and contribute to improvement activities.
• Support Annual Product Reviews and preparation of quality metrics, where needed.
• Help with internal audits, regulatory inspections, and activities that support inspection readiness.
• Carry out all work in accordance with company safety expectations and SOPs.
• Take on additional responsibilities as business needs evolve.

Requirements

• A bachelor’s degree in Science, Engineering, Pharmacy, Biotechnology, or a closely related field.
• At least 5 years of experience in the pharmaceutical or biotechnology sector.
• Hands-on experience with QA oversight of deviations, investigations, CAPAs, and change controls within a GMP setting.
• Solid knowledge of GMP, quality systems, and risk management practices.
• Strong ability to analyse issues, solve problems, communicate clearly, and work with stakeholders.
• Comfort working independently and collaborating across multiple functions.
• Excellent organisation, coordination, communication, and meeting facilitation skills.
• Demonstrated experience contributing to continuous improvement in a regulated environment.

Additional information

This is a contract position based onsite in Dublin, County Dublin, Ireland. The salary/stipend details were not specified in the source information.