QA Specialist - cGMP & Compliance for Bulk Substances

Alexion Pharma Spain S.L.; Athlone; On-site; EUR 70,000 - 90,000; Full time

Job summary

Alexion seeks a QA Specialist for the Bulk Drug Substance facility in Athlone to ensure products meet cGMP and regulatory requirements. You will oversee QA activities, review documentation, and support inspections to maintain product safety and supply.

The role requires a B.Sc. in Science/Engineering with at least 3 years in a cGMP QA environment, strong attention to detail, and excellent communication. Collaboration with Operations, QC, and Engineering is essential.

Qualifications

• B.Sc. in Science/Engineering with ≥3 years in cGMP QA.
• Minimum 3 years’ QA experience in pharma or related field.
• Strong knowledge of cGMP for pharmaceutical manufacturing.
• Direct GMP management experience and interaction with authorities (FDA/HPRA).
• Excellent accuracy, attention to detail, and communication skills.
• Proficient with quality systems and documentation control.

Responsibilities

• Provide QA input and oversight for all manufacturing activities for BDS at Athlone.
• Review/approve technical docs, SOPs, reports, and validation protocols.
• Support inspection readiness and responses to authority observations.
• Oversee Master Batch Records and QMS activities (Deviation, CAPA, Change Control).
• Develop and report quality metrics; collaborate with Ops, QC, and Eng.
• Participate in quality risk assessments and continuous improvement initiatives.

Skills

cGMP Knowledge

QA Experience

Documentation

Communication

Time Management

TrackWise

Education

B.Sc. in Science/Engineering

Tools

TrackWise

Job description

Alexion seeks a QA Specialist for the Bulk Drug Substance facility in Athlone to ensure products meet cGMP and regulatory requirements. You will oversee QA activities, review documentation, and support inspections to maintain product safety and supply.

The role requires a B.Sc. in Science/Engineering with at least 3 years in a cGMP QA environment, strong attention to detail, and excellent communication. Collaboration with Operations, QC, and Engineering is essential.