Night Shift QA Lead, Aseptic Pharma Quality

AstraZeneca plc; Macclesfield; On-site; GBP 52,000 - 74,000; Full time

Job summary

AstraZeneca plc in Macclesfield invites an experienced Senior Specialist – Quality Assurance to lead QA oversight for aseptic manufacturing and packaging on the night shift. You will ensure regulatory compliance, data integrity, and timely product release while guiding the PET team on GMP and aseptic practices.

Responsibilities include deviations/CAPA management, change controls, and quality systems execution, with emphasis on lean improvement and collaboration with cross-functional teams to

Qualifications

• Degree in a scientific discipline with understanding of QA in pharma.
• Strong knowledge of GMP and EU GMP Annex 1 and data integrity principles.
• Experience with aseptic processing or packaging and cleanroom controls.
• Excellent communication and influencing skills; able to coach operators.
• Willingness to work permanent night shift.

Responsibilities

• Provide QA leadership and oversight for aseptic manufacturing and packaging on the night shift.
• Support or perform product release activities ensuring batch documentation and data integrity.
• Advise on deviations, lead root cause analysis, and agree CAPAs.
• Lead or support change controls ensuring regulatory alignment.
• Contribute to PQR, quality risk management, and QA metrics.

Skills

Quality Assurance

Aseptic Processing

GMP

Change Control

Data Integrity

Lean Manufacturing

Communication

Education

Bachelor's degree in a scientific discipline

Tools

PQR system

Job description

AstraZeneca plc in Macclesfield invites an experienced Senior Specialist – Quality Assurance to lead QA oversight for aseptic manufacturing and packaging on the night shift. You will ensure regulatory compliance, data integrity, and timely product release while guiding the PET team on GMP and aseptic practices.

Responsibilities include deviations/CAPA management, change controls, and quality systems execution, with emphasis on lean improvement and collaboration with cross-functional teams to