Night QA Lead – Aseptic Manufacturing & Release

AstraZeneca plc; Macclesfield; On-site; GBP 55,000 - 70,000; Full time

Benefits offered by this job

Competitive salary

Job summary

AstraZeneca plc is seeking a Senior Specialist - Quality Assurance to lead QA oversight for aseptic manufacturing and packaging on the night shift in Macclesfield. You will ensure GMP compliance, support product release, and coach PET personnel on aseptic practices and data integrity.

The role emphasizes risk-based decision making, continuous improvement, and collaboration across functions to safeguard patient safety and regulatory compliance.

Qualifications

• Degree (or equivalent) in a scientific discipline with understanding of QA in a lean manufacturing environment.
• Strong GMP knowledge and experience with EU GMP Annex 1, ICH Q9/Q10 and data integrity.

Responsibilities

• Provide QA leadership for aseptic manufacturing and packaging on the night shift.
• Advise on deviations, lead root cause analysis, and approve CAPAs.
• Support or perform product release activities with batch documentation and data integrity.

Skills

Aseptic processing

GMP knowledge

Deviation & CAPA

Data integrity

Quality assurance

Cross-functional collaboration

Communication

Problem solving

Education

Degree in science

Job description

AstraZeneca plc is seeking a Senior Specialist - Quality Assurance to lead QA oversight for aseptic manufacturing and packaging on the night shift in Macclesfield. You will ensure GMP compliance, support product release, and coach PET personnel on aseptic practices and data integrity.

The role emphasizes risk-based decision making, continuous improvement, and collaboration across functions to safeguard patient safety and regulatory compliance.