Senior QC Analyst - Lead NPI Method Transfer & Validation

Alexion; Blanchardstown; On-site; EUR 65,000 - 90,000; Full time

Job summary

AstraZeneca in Blanchardstown, Ireland is seeking a QC Senior Analyst focused on Analytical NPI to drive method transfer, validation and troubleshooting into robust, inspection-ready outcomes that support clinical and commercial supply.

This role requires strong technical writing, regulatory knowledge and the ability to lead cross-functional investigations with minimal supervision in a fast-paced environment.

Qualifications

• In depth knowledge of regulatory requirements for chemistry/biochemistry methods in cGMP operations.
• Strong background in Biochemistry or Chemistry with experience in investigations.
• Ability to follow procedures with attention to detail and write technical reports.
• Experience with AI-assisted technical writing within compliant boundaries.
• Ability to work with minimal supervision on routine duties.

Responsibilities

• Perform all lab functions in compliance with cGMP, safeguarding data integrity and audit readiness.
• Method transfer and validation: follow protocols and execute studies meeting regulatory timelines.
• Troubleshoot methods and provide SME guidance for NPI activities.
• Lead investigations/CAPAs with clear root cause and preventive actions.
• Training lead for new personnel to ensure qualified performance.
• Drive continuous improvement to increase method robustness and reduce cycle time.
• Evaluate and adopt new analytical technologies to enhance performance.
• Maintain accurate documentation throughout the method lifecycle.

Skills

cGMP knowledge

Biochemistry

Investigation methods

Technical writing

AI in writing

Independent work

Regulatory knowledge

Education

BSc in Chemistry or Biology

Tools

LIMS

Empower/Chromeleon

Job description

AstraZeneca in Blanchardstown, Ireland is seeking a QC Senior Analyst focused on Analytical NPI to drive method transfer, validation and troubleshooting into robust, inspection-ready outcomes that support clinical and commercial supply.

This role requires strong technical writing, regulatory knowledge and the ability to lead cross-functional investigations with minimal supervision in a fast-paced environment.