Night-Shift QA Specialist, Aseptic Manufacturing Compliance

ASTRAZENECA UK LIMITED; Macclesfield; On-site; GBP 60,000 - 85,000; Full time

Job summary

AstraZeneca UK Limited is seeking a Senior Specialist - Quality Assurance to provide on-night QA leadership for aseptic manufacturing and packaging operations, ensuring GMP compliance, data integrity and timely product release.

You will lead deviations and CAPA, coach PET staff on cGMP, and drive continuous improvement in a lean manufacturing environment, safeguarding patient safety and regulatory compliance.

Qualifications

• Requires degree in a scientific discipline and strong QA foundation.
• Experience with GMP and aseptic processing essential.
• Proven ability to lead CAPA and deviation investigations.

Responsibilities

• Provide QA leadership for aseptic manufacturing and night-shift operations.
• Guide deviations, drive CAPA and root-cause analyses to prevent recurrence.
• Support product release activities with batch docs and data integrity checks.
• Coach PET staff on cGMP, aseptic behaviours and contamination control.

Skills

Cleanroom oversight

Aseptic processing

GMP knowledge

CAPA management

Data integrity

Quality release support

Change control

Quality systems

Training and coaching

Risk-based decision making

Education

Bachelor's degree in science/engineering

Job description

AstraZeneca UK Limited is seeking a Senior Specialist - Quality Assurance to provide on-night QA leadership for aseptic manufacturing and packaging operations, ensuring GMP compliance, data integrity and timely product release.

You will lead deviations and CAPA, coach PET staff on cGMP, and drive continuous improvement in a lean manufacturing environment, safeguarding patient safety and regulatory compliance.