Senior Microbiology QC Lead | cGMP & Method Validation

AstraZeneca; Athlone; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

AstraZeneca in Athlone is seeking a Senior QC Specialist to lead microbiology testing and support cGMP operations across the QC team. You will be SME for microbiological and chemical testing, method transfer and verification, and the qualification of new laboratory equipment.

You will drive investigations, review environmental monitoring trends, and help improve laboratory operations, working with Quality, Manufacturing and Projects to ensure compliance, accuracy of results and timely release of

Formación

• Significant experience in a cGMP quality environment.
• Strong knowledge of Sterility Assurance and related microbiology methods.
• Experience with method validation, endotoxin and bioburdent testing.

Responsabilidades

• Act as SME for microbiological and chemical testing.
• Support method transfer, verification and microbiology validation.
• Coordinate qualification of microbiology test methods and equipment.
• Maintain cGMP/GLP standards and regulatory compliance.
• Manage QC records, deviations and investigations.
• Investigate out-of-spec results using RCA techniques.
• Lead quality risk assessments for microbiology activities.
• Review data, validation protocols and microbial reports.
• Prepare documentation for audits and regulatory actions.

Conocimientos

Microbiology testing

cGMP

Root Cause Analysis

Method transfer

Environmental monitoring

Educación

Degree in Microbiology

Descripción del empleo

AstraZeneca in Athlone is seeking a Senior QC Specialist to lead microbiology testing and support cGMP operations across the QC team. You will be SME for microbiological and chemical testing, method transfer and verification, and the qualification of new laboratory equipment.

You will drive investigations, review environmental monitoring trends, and help improve laboratory operations, working with Quality, Manufacturing and Projects to ensure compliance, accuracy of results and timely release of