Senior Specialist - Quality Assurance (night Shift)

AstraZeneca

Macclesfield, United Kingdom
Competitive salary + benefits; not specified; not ...
Night shift availability (4 on, 4 off)
Eu gmp annex 1 knowledge
Aseptic processing and cleanroom oversight
This role is pivotal in safeguarding patient safety, regulatory compliance, and value stream performance within aseptic manufacturing

Job Summary

  • This role is pivotal in safeguarding patient safety, regulatory compliance, and value stream performance within aseptic manufacturing.
  • The Senior Specialist provides technical guidance on cleanroom standards and ensures alignment with EU GMP Annex 1 and internal procedures.
  • Candidates must be available for a permanent night shift schedule to support the Process Execution Team effectively.

Matching Summary

This role is pivotal in safeguarding patient safety, regulatory compliance, and value stream performance within aseptic manufacturing.

Salary

Competitive salary and benefits; Not specified; Not specified

Skills & Requirements

Must-have

  • Night shift availability (4 on, 4 off)
  • EU GMP Annex 1 knowledge
  • Aseptic processing and cleanroom oversight
  • Deviation and CAPA management expertise
  • Data integrity principles application

Nice-to-have

  • Microbiology and environmental monitoring experience
  • Lean manufacturing environment understanding
  • Cross-functional coaching and influencing skills
  • FMEA and HACCP risk management application

Key Requirements

  • Degree in scientific discipline (pharmacy, microbiology, chemistry, etc.)
  • Strong understanding of pharmaceutical QA function
  • Experience with sterile packaging lines preferred

Work Rights

Not specified

Tailored Resume

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