Shift QA Specialist - Pharma Manufacturing & Compliance

Alexion Pharmaceuticals, Inc.; Ireland; Remote; EUR 55,000 - 75,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. in Athlone, Ireland, seeks a QA Specialist for a 24-month secondment/FTC.

The role provides QA oversight of manufacturing, with on-the-floor support for Drug Substance and Drug Product operations, ensuring cGMP compliance and timely release of products. You will collaborate with Operations, Quality, and Engineering, participate in deviations, CAPAs, and document reviews, and contribute to continuous improvement and digital quality initiatives; shift-based duties

Qualifications

• Experience in a Quality Assurance environment within pharmaceutical/biopharmaceutical industry.
• Strong knowledge of cGMP requirements and pharmaceutical manufacturing regulations.
• Experience interacting with regulatory bodies (FDA, HPRA or equivalents).
• Experience using electronic quality management systems such as TrackWise or similar.
• Excellent attention to detail and a commitment to quality and compliance.

Responsibilities

• Provide QA oversight and cGMP support for manufacturing activities across Drug Substance and Drug Product facilities.
• Deliver on-floor QA support during manufacturing operations and ensure compliance with procedures and QMS.
• Act as primary QA contact during assigned shift, providing real-time guidance and decision-making.
• Assess manufacturing events and deviations, evaluating impacts on quality, safety, and supply.
• Review and approve Master Batch Records and quality documentation, including SOPs and reports.
• Support inspection readiness activities and responses to regulatory inspections.

Skills

Attention to detail

Communication skills

Stakeholder management

Planning and prioritisation

Shift-based work understanding

Education

Bachelor's degree in Science/Engineering

Tools

TrackWise

Job description

Alexion Pharmaceuticals, Inc. in Athlone, Ireland, seeks a QA Specialist for a 24-month secondment/FTC.

The role provides QA oversight of manufacturing, with on-the-floor support for Drug Substance and Drug Product operations, ensuring cGMP compliance and timely release of products. You will collaborate with Operations, Quality, and Engineering, participate in deviations, CAPAs, and document reviews, and contribute to continuous improvement and digital quality initiatives; shift-based duties