QA Specialist - Night Shift, 24-Month FTC (cGMP)

AstraZeneca GmbH

Athlone

On-site

EUR 60,000 - 80,000

Full time

7 days ago
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Job summary

Alexion, based in Athlone, Ireland, seeks a QA Specialist for a 24-month secondment/FTC to oversee QA activities during manufacturing operations at the Bulk Drug Substance and Drug Product facilities.

The role requires hands-on quality guidance, deviation assessments, and collaboration with Operations, Quality Control and Engineering to ensure GMP compliance and product quality for commercial and clinical products.

Qualifications

  • Bachelor's degree in Science, Engineering or related discipline.
  • Experience in QA within pharma/biopharma.
  • Knowledge of cGMP and regulatory requirements.

Responsibilities

  • Provide QA oversight and cGMP support across Drug Substance and Drug Product facilities.
  • Review and approve quality documentation (SOPs, work instructions, reports).
  • Act as primary quality contact during assigned shift and support regulatory inspections.

Skills

QA oversight
cGMP
TrackWise
Shifts
Regulatory liaison

Education

Bachelor's degree in Science/Engineering

Tools

TrackWise

Job description

Alexion, based in Athlone, Ireland, seeks a QA Specialist for a 24-month secondment/FTC to oversee QA activities during manufacturing operations at the Bulk Drug Substance and Drug Product facilities.

The role requires hands-on quality guidance, deviation assessments, and collaboration with Operations, Quality Control and Engineering to ensure GMP compliance and product quality for commercial and clinical products.

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