QA Packaging & Compliance Specialist — GMP & Inspections

Alexion Pharmaceuticals, Inc.; Dublin; Hybrid; EUR 85,000 - 110,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. is seeking a Quality Assurance professional at its College Park site in Ireland to provide quality oversight of packaging activities, including NPI/Qualification for finished products.

This role ensures GMP compliance across testing, packaging, labeling, and storage in line with QMS and regulatory standards. You will interact with Operations, QPs, Device Quality, External Quality, NPI, QC, Engineering and Supply Chain to optimize patient supply and drive continuous

Qualifications

• Bachelor's degree in science, engineering or equivalent QA experience
• Experience in international pharma/biotech packaging preferred
• Strong understanding of quality and regulatory requirements
• Ability to prioritize in a fast-paced environment with multiple stakeholders

Responsibilities

• Perform issuance and review of batch documentation, changes, complaints, deviations, and annual product quality reviews related to College Park operations.
• Support the QP team in preparation and review of documentation for QP release.
• Provide QA input, oversight and guidance to deviations and investigations to ensure robust root cause analysis and timely CAPA closure.
• Generation and reporting of quality metrics.
• Review and approval of SOPs, PIs, Work Instructions, technical reports and protocols.
• Participate in quality risk assessments and maintain quality risk control.
• Author, review and approval of QAGs.
• Lead investigation actions assigned to College Park from the complaints process.
• Provide support for inspection readiness activities during health authority inspections, including responses to observations.
• Support the drive of Quality Culture and continuous improvements at College Park.

Skills

Quality oversight

GMP knowledge

Cross-functional collaboration

Documentation review

Regulatory understanding

Education

Bachelor's degree in science or engineering

Job description

Alexion Pharmaceuticals, Inc. is seeking a Quality Assurance professional at its College Park site in Ireland to provide quality oversight of packaging activities, including NPI/Qualification for finished products.

This role ensures GMP compliance across testing, packaging, labeling, and storage in line with QMS and regulatory standards. You will interact with Operations, QPs, Device Quality, External Quality, NPI, QC, Engineering and Supply Chain to optimize patient supply and drive continuous