Quality Assurance Lead, Drug Product

AstraZeneca plc; Athlone Municipal District; On-site; EUR 52,000 - 76,000; Full time

Job summary

AstraZeneca plc is seeking a QA Specialist for the Drug Product facility at Athlone to ensure products are manufactured in accordance with cGMP and regulatory requirements. The role oversees QA activities and the site QMS, collaborating with Operations, QC, and Technical Services to optimize patient supply.

The successful candidate will review documentation, support inspection readiness, and drive continuous improvement in quality metrics while maintaining compliance across manufacturing

Qualifications

• B.Sc. in Science/Engineering or equivalent with strong cGMP QA experience.
• Minimum 3 years’ QA experience in pharma.
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing.

Responsibilities

• Provide quality and cGMP input and oversight for all manufacturing activities for the Drug Product facility.
• Review and approve technical support documentation (e.g., cleaning, process, method validation).
• Review and approve functional area documentation (SOPs, work instructions, technical reports, protocols).
• Participate in quality risk assessments and provide oversight to ensure assessments are maintained.
• Review and approve Validation protocols as required.
• Support inspection readiness activities during health authority inspections and coordinate with inspectors.

Skills

Quality Assurance

cGMP knowledge

Documentation review

Interdepartmental collaboration

Planning and organizing

Time management

Education

B.Sc. in Science/Engineering

Tools

TrackWise

Job description

AstraZeneca plc is seeking a QA Specialist for the Drug Product facility at Athlone to ensure products are manufactured in accordance with cGMP and regulatory requirements. The role oversees QA activities and the site QMS, collaborating with Operations, QC, and Technical Services to optimize patient supply.

The successful candidate will review documentation, support inspection readiness, and drive continuous improvement in quality metrics while maintaining compliance across manufacturing