Aseptic QA Specialist – Quality & Compliance

AstraZeneca; Macclesfield; On-site; GBP 42,000 - 54,000; Full time

Job summary

AstraZeneca is seeking a Quality Specialist for a 12-month secondment/FTC to provide QA support for aseptic manufacturing and ensure operations meet GMP standards. You will influence decisions through technical advice and maintain compliance across production and QC activities.

The role covers deviation handling, investigations, and participation in audits, with a focus on continuous improvement and maintaining high quality throughout manufacturing and testing environments.

Qualifications

• Qualified to degree level or equivalent in one of the sciences or with working experience in a GMP environment.
• Sound knowledge of aseptic manufacture and GMP principles.
• Knowledge of GMP requirements related to technical expertise and regulatory processes.

Responsibilities

• Provide Quality Assurance support to the manufacturing team.
• Offer technical advice on GMP requirements, quality standards, and compliance impact.
• Support investigations and ensure root cause analysis and CAPA are implemented.
• Triage, review and close deviations and associated investigations within timelines.
• Participate in audits and inspections and maintain high quality standards in production and QC testing.

Education

Degree in science

Tools

MSDM documentation

Job description

AstraZeneca is seeking a Quality Specialist for a 12-month secondment/FTC to provide QA support for aseptic manufacturing and ensure operations meet GMP standards. You will influence decisions through technical advice and maintain compliance across production and QC activities.

The role covers deviation handling, investigations, and participation in audits, with a focus on continuous improvement and maintaining high quality throughout manufacturing and testing environments.