QA Specialist, Drug Product - cGMP & Compliance Leader

Alexion Pharma Spain S.L.; Athlone; Remote; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

Alexion Pharma Spain S.L. in Athlone, Ireland seeks a QA Specialist to oversee Drug Product QA activities, ensuring cGMP compliance in manufacturing, testing, labeling, and storage. You will interact with Operations, QC, Technical Services and Engineering to protect product safety and supply.

You will review validation protocols, master records and QA documentation, support inspection readiness and drive quality metrics across the site.

Qualifikationen

• B.Sc. in Science/Engineering with GMP knowledge required.
• Minimum 3 years in a QA environment in pharma/biopharma.
• Experience with FDA/HPRA inspections is preferred.
• Strong attention to detail and communication skills.

Aufgaben

• Provide QA input and oversight for Drug Product manufacturing activities.
• Review/approve technical docs, SOPs, work instructions and protocols.
• Participate in quality risk assessments and CAPA management.
• Support inspection readiness and responses to observations.
• Review Master Batch Records and change controls.
• Oversee calibration/PM activities and QMS metrics.

Kenntnisse

cGMP knowledge

Quality Assurance

Documentation review

TrackWise

Regulatory inspections

Quality metrics

Project collaboration

Ausbildung

B.Sc. in Science/Engineering

Tools

TrackWise

Jobbeschreibung

Alexion Pharma Spain S.L. in Athlone, Ireland seeks a QA Specialist to oversee Drug Product QA activities, ensuring cGMP compliance in manufacturing, testing, labeling, and storage. You will interact with Operations, QC, Technical Services and Engineering to protect product safety and supply.

You will review validation protocols, master records and QA documentation, support inspection readiness and drive quality metrics across the site.