Senior QA Specialist – Aseptic Manufacturing (Night Shift)

AstraZeneca plc; Macclesfield; Sur place; GBP 60 000 - 90 000; Plein temps

Résumé du poste

AstraZeneca plc is seeking a Senior Specialist - Quality Assurance to lead QA for aseptic manufacturing and packaging on the night shift at Macclesfield. You will provide GMP and aseptic processing expertise, ensure cleanroom compliance, and support timely product release.

This role safeguards patient safety and regulatory compliance while contributing to value stream performance. Essential experience includes strong GMP knowledge, aseptic processing, and cross-functional collaboration in lean

Qualifications

• Degree in a scientific discipline with a clear grasp of quality assurance and lean manufacturing.
• Strong GMP knowledge with EU GMP Annex 1, ICH Q9/Q10, and data integrity principles.
• Aseptic processing or packing knowledge, including cleanroom behaviours and contamination control.
• Cross-functional collaboration in a lean manufacturing environment.
• Excellent communication and influencing skills, with ability to coach operators and technicians.

Responsabilités

• Provide QA leadership and oversight for aseptic manufacturing and packaging operations on the night shift.
• Advise on deviations, lead or contribute to root cause analyses, and agree CAPAs.
• Support product release activities ensuring batch documentation and data integrity.
• Lead or support change controls ensuring validated state and regulatory alignment.
• Contribute to quality systems execution, including PQR, quality risk management, and metric updates.

Connaissances

Quality assurance

Lean manufacturing

GMP knowledge

Communication skills

Decision making

Night shift

Formation

Degree in scientific discipline

Description du poste

AstraZeneca plc is seeking a Senior Specialist - Quality Assurance to lead QA for aseptic manufacturing and packaging on the night shift at Macclesfield. You will provide GMP and aseptic processing expertise, ensure cleanroom compliance, and support timely product release.

This role safeguards patient safety and regulatory compliance while contributing to value stream performance. Essential experience includes strong GMP knowledge, aseptic processing, and cross-functional collaboration in lean