QA Specialist, Drug Product

AstraZeneca
Athlone, Leinster, Ireland
Full Time
On Site
Mid
0+
Bachelor Degree
Healthcare Healthcare Life Sciences

Posted 3 days ago

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Excellent 4.7

Job summary

The QA Specialist for the Drug Product (DP) facility at AAMF is responsible for quality assurance activities ensuring products are manufactured in compliance with cGMP, regulatory, and corporate standards. The role involves overseeing manufacturing, testing, labeling, storage, document review, validation, risk assessments, inspection readiness, and managing quality systems related to deviations, CAPA, change control, and supplier qualification. The position requires ensuring product safety, quality, and efficacy, with interaction across departments including Operations, QC, and Technical Services.

Responsibilities

The QA Specialist oversees quality assurance activities for drug product manufacturing to ensure compliance with cGMP and regulatory requirements. This role involves reviewing technical documentation, managing quality systems, and supporting inspection readiness to ensure product safety and efficacy.

Qualifications

cGMP Deviation Management FDA GMP Inspection Readiness Quality Assurance Quality Management System Regulatory Compliance Risk Assessment Validation

Candidates must hold a B.Sc. in Science or Engineering with at least 3 years of experience in a cGMP quality environment within the pharmaceutical industry. Strong knowledge of regulatory requirements and experience with quality management systems are essential for this position.

English

Benefits

Reasonable adjustments and accommodations

Company

AstraZeneca

AstraZeneca

linkedin
Pharmaceutical Manufacturing
Location
Athlone, Leinster, Ireland

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Excellent 4.7
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