Senior QA Specialist - GMP & Compliance (Pharma)

Alexion Pharmaceuticals, Inc.; Athlone; On-site; EUR 65,000 - 85,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. in Athlone, Ireland seeks a QA Specialist for the Bulk Drug Substance facility to ensure cGMP compliance and regulatory alignment.

You will oversee QA activities for manufacturing, testing, labeling, and storage of bulk drug substances, coordinating with Operations, QC, and Technical Services to protect product quality and patient safety. You will review and approve docs, participate in risk assessments, manage CAPA and inspection readiness, and lead Master Batch

Qualifications

• B.Sc. in Science/Engineering with a minimum of 3 years’ experience in a cGMP QA environment.
• Minimum 3 years’ pharma QA experience; knowledge of cGMP requirements.
• Experience with GMP management and regulatory inspections (FDA/HPRA) desirable.

Responsibilities

• Provide QA input and oversight for all manufacturing activities at the Bulk Drug Substance facility.
• Review and approve technical docs (cleaning, process & method validation).
• Review SOPs, Work Instructions, and technical reports.
• Participate in quality risk assessments and CAPA management.
• Respond to inspection findings and support readiness.
• Review and approve Master Batch Records per GMP.
• Oversee calibration, maintenance, and QMS activities.

Skills

Quality Assurance

cGMP Knowledge

Documentation Review

Communication Skills

Inspection Readiness

Education

B.Sc. in Science/Engineering

Tools

TrackWise

MS Office

Job description

Alexion Pharmaceuticals, Inc. in Athlone, Ireland seeks a QA Specialist for the Bulk Drug Substance facility to ensure cGMP compliance and regulatory alignment.

You will oversee QA activities for manufacturing, testing, labeling, and storage of bulk drug substances, coordinating with Operations, QC, and Technical Services to protect product quality and patient safety. You will review and approve docs, participate in risk assessments, manage CAPA and inspection readiness, and lead Master Batch