QA Validation Specialist: Documentation & Compliance

Alexion Pharmaceuticals, Inc.; Athlone; On-site; EUR 60,000 - 85,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. in Ireland seeks a QA Validation Specialist to support validation activities for cGMP manufacture. You will review and approve validation documents including policies, master plans, procedures, specifications, investigations, protocols and reports.

The role requires 3-5 years in quality/validation, a science degree, and strong attention to detail with excellent communication and problem-solving skills. Office-based with GMP environment experience is preferred.

Qualifications

• Primary Degree in Science
• Post-graduate studies as appropriate to augment degree
• 3-5 years’ experience in Quality/validation environment. Drug Product and Drug Substance experience
• Excellent attention to detail
• Good communication, teamwork and problem solving skills
• Office-based role in pharmaceutical manufacturing environment
• Ability to use computer, communicate via phone/video/electronic messaging; collaborate with others during standard business hours

Responsibilities

• Maintenance of a strong Quality culture throughout the project through operational activities.
• Provide QA support for risk based verification activities as QA Subject Matter Expert; review and approval of equipment/utilities verification documentation from design to post execution.
• Lead and/or participate in investigations of non-conformances and follow-up corrective/preventive actions in line with quality procedures and regulations.
• Participate in verification quality risk assessments and provide quality oversight to ensure they are effectively maintained and controlled.
• Ensure QA support to internal manufacturing and technical groups; review and approve functional area documentation (SOPs, Work Instructions, Criticality Assessments, technical reports and protocols).
• Authoring, review and approval of QA validation-related procedures; review and approve Validation protocols (e.g., cleaning, process, method validation).
• Support the vendor quality management programme; complete audits as required; develop and report quality metrics for validation/verification.

Skills

Attention to detail

Communication

Teamwork

Problem solving

Education

Primary Degree in Science

Post-graduate studies

Tools

Trackwise

SAP

Vault Quality

Job description

Alexion Pharmaceuticals, Inc. in Ireland seeks a QA Validation Specialist to support validation activities for cGMP manufacture. You will review and approve validation documents including policies, master plans, procedures, specifications, investigations, protocols and reports.

The role requires 3-5 years in quality/validation, a science degree, and strong attention to detail with excellent communication and problem-solving skills. Office-based with GMP environment experience is preferred.