QA Specialist – Finished Product

Alexion Pharmaceuticals, Inc.; Dublin; Hybrid; EUR 85.000 - 110.000; Vollzeit

Zusammenfassung

Alexion Pharmaceuticals, Inc. is seeking a Quality Assurance professional at its College Park site in Ireland to provide quality oversight of packaging activities, including NPI/Qualification for finished products.

This role ensures GMP compliance across testing, packaging, labeling, and storage in line with QMS and regulatory standards. You will interact with Operations, QPs, Device Quality, External Quality, NPI, QC, Engineering and Supply Chain to optimize patient supply and drive continuous

Qualifikationen

• Bachelor's degree in science, engineering or equivalent QA experience
• Experience in international pharma/biotech packaging preferred
• Strong understanding of quality and regulatory requirements
• Ability to prioritize in a fast-paced environment with multiple stakeholders

Aufgaben

• Perform issuance and review of batch documentation, changes, complaints, deviations, and annual product quality reviews related to College Park operations.
• Support the QP team in preparation and review of documentation for QP release.
• Provide QA input, oversight and guidance to deviations and investigations to ensure robust root cause analysis and timely CAPA closure.
• Generation and reporting of quality metrics.
• Review and approval of SOPs, PIs, Work Instructions, technical reports and protocols.
• Participate in quality risk assessments and maintain quality risk control.
• Author, review and approval of QAGs.
• Lead investigation actions assigned to College Park from the complaints process.
• Provide support for inspection readiness activities during health authority inspections, including responses to observations.
• Support the drive of Quality Culture and continuous improvements at College Park.

Kenntnisse

Quality oversight

GMP knowledge

Cross-functional collaboration

Documentation review

Regulatory understanding

Ausbildung

Bachelor's degree in science or engineering

Jobbeschreibung

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.
• 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.
• undefined

You will need to have:

• Bachelor's degree in science, engineering or equivalent QA experiencein 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.