Senior Specialist QA

AstraZeneca
Ireland
Full timeFunction: QA, Test & Release EngineeringExperience: 7+ yearsSkills: ["Root cause analysis","Problem-solving","Auditing","Technical writing","Communication"]

Anchor quality assurance across AstraZeneca’s Irish manufacturing sites to ensure clinical and commercial products meet cGMP, corporate, and regulatory requirements. Serve as the QA point person for cross-functional teams, overseeing GMP documentation, batch review, deviation investigations, and risk-proportionate CAPA. Support technology transfer and new product introductions, provide validation oversight, sustain audit readiness, and use digital quality metrics to drive continuous improvement and reliable batch release.

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FursaFursa
AstraZeneca
AstraZeneca
3 hours ago

Senior Specialist QA

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Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 3 hours agoStatus: Live
Reposted: similar role first listed 4 months ago

Job Summary

Anchor quality assurance across AstraZeneca’s Irish manufacturing sites to ensure clinical and commercial products meet cGMP, corporate, and regulatory requirements. Serve as the QA point person for cross-functional teams, overseeing GMP documentation, batch review, deviation investigations, and risk-proportionate CAPA. Support technology transfer and new product introductions, provide validation oversight, sustain audit readiness, and use digital quality metrics to drive continuous improvement and reliable batch release.
Location: Ireland
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Mid level

Key Responsibilities

  • •Provide QA/compliance technical leadership to safeguard product quality and ensure uninterrupted supply across Irish manufacturing sites.
  • •Maintain and execute GMP documentation and batch review schedules, including SOPs, master batch records, validation materials, and policies.
  • •Lead and support deviations and CAPA using root cause analysis and risk-proportionate corrective and preventive actions.
  • •Support technology transfer and new product introductions with compliant, validated, inspection-ready implementation; provide validation oversight.
  • •Maintain audit readiness and support internal audits and regulatory inspections, using digital quality metrics and KPIs to drive continuous improvement.

Key Requirements

  • •7+ years of relevant pharma industry experience and a third-level qualification (e.g., B.Sc. in science/pharmacy) or equivalent education and experience in a cGMP Quality environment.
  • •Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging.
  • •Direct GMP management experience in pharma/biopharma, including exposure to FDA and/or HPRA/EMA or similar authorities.
  • •Direct experience of New Product Introduction and quality processes across multiple areas.
  • •Experience implementing digital tools for QA reporting/documentation/analysis and working with quality computer packages such as TrackWise.
Experience:7+ yearsPharmaBiopharmaCGMP
Skills:Root cause analysisProblem-solvingAuditingTechnical writingCommunication
Tech Stack:CGMPTrackWise

Company Brief

AstraZeneca
Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.
Industry: Pharmaceuticals
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Cambridge, United Kingdom
Founded: 1999
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