Senior QA IT Specialist - GxP Systems & AI Assurance

Alexion Pharma Spain S.L.; Dublin; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

AstraZeneca invites applications for a Senior Specialist, QA IT in Dublin to provide independent QA oversight for GxP computerised systems across their lifecycle. You will partner with business process owners, system owners, IT and external suppliers to ensure compliance, security and data integrity.

The role requires applying ALCOA++ data integrity, reviewing validation plans, risk assessments, testing strategies and release decisions, while supporting audits and inspections and driving

Qualifications

• Provides QA oversight for GxP computerised systems and digital solutions across their lifecycle.
• Reviews intended use, GxP impact, risk assessments, validation or assurance plans, and release decisions.
• Ensures data integrity controls meet ALCOA++ principles, including access, audit trails, electronic records and signatures.

Responsibilities

• Acts as QA IT lead for assigned portfolio of GxP systems or functions.
• Reviews solution architecture and control design from a quality perspective.
• Assesses supplier capability, supports supplier audits, and defines reliance and change-notification expectations.
• Owns Computer System Inventory for control and oversight of IT GxP systems.
• Supports implementation and governance of digital technologies while ensuring validated state is maintained.

Job description

AstraZeneca invites applications for a Senior Specialist, QA IT in Dublin to provide independent QA oversight for GxP computerised systems across their lifecycle. You will partner with business process owners, system owners, IT and external suppliers to ensure compliance, security and data integrity.

The role requires applying ALCOA++ data integrity, reviewing validation plans, risk assessments, testing strategies and release decisions, while supporting audits and inspections and driving