QA Specialist – Finished Product

AstraZeneca; Dublin; On-site; EUR 70,000 - 110,000; Full time

Job summary

AstraZeneca in Ireland is seeking a Quality Assurance professional to oversee packaging activities, including NPI/Qualification for Finished Product, ensuring all testing, labeling, storage comply with QMS and cGMP standards. You will collaborate with Operations, QPs, Device Quality, External Quality, NPI, QC, Engineering and Supply Chain to optimise patient supply.

You will issue and review batch documentation, support QP release, lead investigations, and drive continuous improvements within

Qualifications

• Bachelor's degree in science, engineering or equivalent QA experience in international pharmaceutical and/or biotech industry with packaging experience a preference and advantage.
• Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements.
• Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment.
• Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization.
• Strong verbal and written communication skills with well-structured communication and presentation ability.

Responsibilities

• Provide Quality oversight of packaging activities including NPI/Qualification for Finished Product Commercial and Clinical product at the College Park facility.
• Ensure testing, packaging, labeling, storage of Alexion products comply with QMS and all applicable regulations including cGMP Biopharmaceutical and Medical Device quality standards.
• Interact with Operations, QPs, Device Quality, External Quality, NPI, QC, Engineering and Supply Chain to optimise patient supply.
• Issue and review batch documentation, manage changes, complaints, deviations, and annual product quality reviews for College Park operations.
• Support the QP team in preparation and review of documentation for QP release.
• Provide Quality input and oversight for investigations to ensure robust root cause analysis and timely closure as per SOPs and QMS.
• Generate and report quality metrics.
• Review and approve functional area documentation (SOPs, PIs, Work Instructions, technical reports and protocols).
• Participate in quality risk assessments and maintain quality risk assessments.
• Author, review and approve QAGs.
• Lead investigation actions assigned to College Park from complaints processes.
• Support inspection readiness activities during health authority inspections and coordinate responses to observations.
• Support Quality Culture and continuous improvements at College Park.

Job description

This is what you will do:

Responsible, with management support, for providing Quality oversight of Packaging activities including NPI/Qualification for Finished Product Commercial and Clinical product at the College Park facility. Responsible for ensuring that testing, packaging, labelling, storage of Alexion products comply with QMS and all applicable regulations including including cGMP Biopharmaceutical and Medical Device quality standards.

This role ensures effective interaction with other departments and locations regarding GMP document review and finished product release and partnering with major stakeholders such as Operations, QPs, Device Quality, External Quality , NPI, QC, Engineering and Supply Chain to optimise patient supply.

You will be responsible for:

• Perform issuance and review of batch documentation, management of changes, complaints, deviations, and annual product quality reviews related to College Park operations.
• Support the QP team, in relation to preparation and review of the relevant documentation for QP release.
• Provide Quality input, oversight and guidance to Alexion deviations and investigations to ensure robust root cause analysis/CAPA definition and timely closure as per Alexion SOPs and QMS.
• Generation and reporting of quality metrics.
• Review and approval of functional area documentation (SOPs, PIs , Work Instructions, technical reports and protocols).
• Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
• Author, Review and Approval of QAGs.ivli>
• Leading investigtion actions assigned to College Park from complaints process.
• Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
• Support the drive of Quality Culture and support implementation of continuous improvements at College Park.
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You will need to have:

• Bachelor's degree in science, engineering or equivalent QA experience in international pharmaceutical and/or biotech industry with packaging experience a preference and advantage.
• Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements
• Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment
• Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization
• Strong verbal and written communication skills with well-structured communication and presentation ability.

Date Posted 19-Oct-2026

Closing Date 23-Oct-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.