QA Specialist (Extended Days)

AstraZeneca
Dublin
Workplace: OnsiteFull timeFunction: QA, Test & Release EngineeringEducation: bachelorsSkills: ["Communication","Presentation","Leadership","Cross-functional influence","Ability to work in a complex environment"]

Support QA oversight for AstraZeneca’s Bulk Drug Substance facility at ADMF, ensuring GMP compliance across manufacturing, testing, documentation, and product disposition. Review and approve batch records and validation/technical documentation, oversee QMS activities (deviations, change control, calibration, preventive maintenance), and provide quality risk assessment oversight. Maintain inspection readiness and partner with Operations, QC, Engineering, Supply Chain, and QPs to safeguard uninterrupted patient supply.

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AstraZeneca
AstraZeneca
1 day ago

QA Specialist (Extended Days)

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Last checked: 2 hours agoStatus: Live

Job Summary

Support QA oversight for AstraZeneca’s Bulk Drug Substance facility at ADMF, ensuring GMP compliance across manufacturing, testing, documentation, and product disposition. Review and approve batch records and validation/technical documentation, oversee QMS activities (deviations, change control, calibration, preventive maintenance), and provide quality risk assessment oversight. Maintain inspection readiness and partner with Operations, QC, Engineering, Supply Chain, and QPs to safeguard uninterrupted patient supply.
Location: Dublin
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering

Key Responsibilities

  • •Provide quality and cGMP oversight for commercial manufacturing activities in the BDS facility.
  • •Review and approve executed batch records, Master Batch Records, and electronic batch record recipes.
  • •Review and approve technical documentation, including cleaning, process, and method validation; and approve SOPs, work instructions, and protocols.
  • •Oversee QMS elements including deviations, change control, calibration, and preventive maintenance.
  • •Support inspection readiness, provide QA oversight for quality risk assessments, and participate directly with health authority inspectors.

Key Requirements

  • •Fluency in written and spoken English.
  • •Experience in the pharmaceutical or biotech industry.
  • •Solid understanding of GMP, quality systems, and regulatory expectations.
  • •Strong communication and presentation skills with the ability to influence cross-functionally.
  • •Degree in Pharmacy, Biology, Biotechnology, Engineering, or another relevant scientific discipline.
Experience:PharmaceuticalBiotechBiologics
Education:Bachelor's
Skills:CommunicationPresentationLeadershipCross-functional influenceAbility to work in a complex environment
Languages:English
Tech Stack:GMPCGMPQuality Management System (QMS)Batch recordsMaster Batch RecordsElectronic batch recordsSOPsDeviationsChange controlCalibrationPreventive maintenanceQuality risk assessments

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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