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AstraZeneca

Specialist - Quality Assurance - 12 Month Secondment/FTC

Posted 3 Days Ago
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In-Office
Macclesfield, Cheshire, England
Mid level
In-Office
Macclesfield, Cheshire, England
Mid level
Provide QA support for aseptic manufacturing to ensure GMP compliance. Activities include reviewing batch records, triaging and closing deviations, supporting investigations and CAPAs, complaints management, conducting self-inspections, training personnel, managing change control, and participating in regulatory/internal audits.
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Specialist Quality (12 Month Secondment/FTC)

Introduction to role:

Join us as a Quality Specialist and provide QA support for aseptic manufacturing, ensuring that operation meet all the regulatory and AstraZeneca standards and the appropriate level of compliance. Your role will directly impact the value stream by supporting and influencing decisions through advice to others.

Accountabilities:

  • Provide Quality Assurance support to the manufacturing team
  • Provide technical advice on GMP requirements, quality standards, and the compliance impact of manufacturing and operational activities
  • Support investigations and ensure appropriate root cause analysis and effective corrective and preventative actions are implemented
  • Triage, review and close deviations and associated investigations within agreed timelines
  • Support the complaints management process and, where appropriate, review and approve complaint investigations
  • Maintain and develop your professional capability
  • Provide training and coaching to personnel
  • Perform MSDM documentation updates
  • Conduct self-inspections and observations
  • Review batch records
  • Manage OCM Change control
  • Proactively suggest improvements to enhance quality compliance
  • Maintain high quality standards in production and QC testing clean rooms
  • Participate in regulatory and internal audits and inspections

Essential Skills/Experience:

  • Qualified to degree level or equivalent in one of the sciences or with working experience in a GMP environment.
  • Sound knowledge and understanding of the principles of aseptic manufacture and associated GMPs.
  • Essential Functional Capability at the Professional level in Aseptic Manufacture and Environmental Control.
  • Knowledge of Current GMP requirements related to technical expertise and regulatory processes.

Desirable Skills/Experience:

  • Experience with deviation management, change controls, complaints and batch record reviews
  • Experience driving continuous improvement initiatives within a GMP environment
  • Understanding of Product Quality Reviews and audit/inspection management

AstraZeneca offers a unique opportunity to be at the forefront of quality assurance, where your work is both important and valued. Our forward-looking mindset allows you to add real value throughout the lifecycle of our products, from discovery to commercialization. As the voice of the patient, every batch you certify is a personal stamp of approval. We are always innovating, trialing the latest models and technologies to improve reliability and excellence in our processes. Here, you'll feel empowered to make decisions that put patients first, working in a collaborative environment that values each voice.

Ready to make a difference? Apply now to join our team!

Date Posted

31-Jul-2026

Closing Date

14-Aug-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca Manchester, England Office

Manchester, United Kingdom, 0

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