Senior QC Analyst, NPI Method Transfer & Validation

AstraZeneca plc; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

AstraZeneca plc in Ireland seeks a QC Senior Analyst focused on Analytical NPI to anchor method transfer, validation, and troubleshooting for clinical and commercial supply. The role emphasizes accuracy, compliance, and impact on patient access.

You will support investigations, CAPAs, and training, shaping robust analytics while advancing new technologies to improve data quality and lab efficiency.

Qualifications

• In-depth knowledge of regulatory requirements for chemistry or biochemistry methods in cGMP ops.
• Strong technical background in chemistry or biochemistry with lab experience.
• Experience in investigations, method troubleshooting and data analysis.

Responsibilities

• Perform cGMP lab activities with audit readiness and data integrity.
• Lead transfers, validations, and troubleshooting for NPI methods.
• Provide SME support and technical leadership for investigations/CAPAs.
• Oversee training for new personnel to ensure qualified performance.
• Drive continuous improvement to reduce cycle times and improve workflows.
• Evaluate new analytical technologies to boost performance and quality.
• Maintain documentation and support readiness across method lifecycle.

Skills

Regulatory knowledge

Biochemistry/Chemistry

Investigation methods

Technical writing

AI-assisted writing

Independent work

Education

BSc in Chemistry or biological science

Tools

LIMS

Empower/Chromeleon

Electronic quality systems

Job description

AstraZeneca plc in Ireland seeks a QC Senior Analyst focused on Analytical NPI to anchor method transfer, validation, and troubleshooting for clinical and commercial supply. The role emphasizes accuracy, compliance, and impact on patient access.

You will support investigations, CAPAs, and training, shaping robust analytics while advancing new technologies to improve data quality and lab efficiency.