GMP QA Validation Lead — Risk‑Based Verification

Alexion Pharma Spain S.L.; Ireland; Remote; EUR 65,000 - 85,000; Full time

Job summary

Alexion seeks a QA Validation Specialist in Ireland to support cGMP manufacturing activities across commercial and clinical requirements. You will review and approve validation documents, policies, plans and reports, ensuring QA oversight of processes from design through execution.

The role requires a science degree, 3–5 years in a quality/validation environment, and strong attention to detail with excellent communication and teamwork skills.

Qualifications

• Primary Degree in Science.
• Post-graduate studies as appropriate to augment degree.
• 3-5 years' experience in Quality/validation environment; Drug Product/Drug Substance experience.
• Excellent attention to detail.
• Good communication, teamwork and problem solving skills.
• Office and pharmaceutical manufacturing environment experience.

Responsibilities

• Maintain a strong Quality culture through project activities.
• Provide QA support for risk-based verification activities as SME; review equipment/utilities verification docs from design to post-execution.
• Lead and/or participate in investigation of non-conformances and follow-up CAPA.
• Participate in verification quality risk assessments and provide quality oversight.
• Review and approve functional area documentation (SOPs, Work Instructions, Criticality Assessments, technical reports, protocols).
• Author, review and approve QA validation-related procedures.
• Review and approve Validation protocols (e.g., cleaning, process, and method validation).
• Support vendor quality management program; complete audits as required.
• Develop and report quality metrics for validation/verification.
• Provide QA oversight of calibration and maintenance criticality assessments.
• Interface with relevant departments to ensure GMP and regulatory compliance.

Skills

Quality Assurance

Validation

Documentation

Communication

Problem solving

Education

Science degree

Post-graduate studies

Tools

Trackwise

SAP

Vault Quality

GMP

Job description

Alexion seeks a QA Validation Specialist in Ireland to support cGMP manufacturing activities across commercial and clinical requirements. You will review and approve validation documents, policies, plans and reports, ensuring QA oversight of processes from design through execution.

The role requires a science degree, 3–5 years in a quality/validation environment, and strong attention to detail with excellent communication and teamwork skills.