Senior Specialist Quality Assurance - 12 Month Secondment/ftc

AstraZeneca

Macclesfield, United Kingdom
Aseptic manufacturing experience
Quality systems knowledge
Regulatory compliance procedures
Provide QA expertise and support for manufacturing and packaging to ensure regulatory and AstraZeneca standards are met

Job Summary

  • Provide QA expertise and support for manufacturing and packaging to ensure regulatory and AstraZeneca standards are met.
  • Participate in quality initiatives and improvement projects to deliver enhanced compliance at a reduced cost.
  • Responsible for professional management of adverse events and all associated quality management systems within the Process Execution Team (PET) you support.

Matching Summary

Provide QA expertise and support for manufacturing and packaging to ensure regulatory and AstraZeneca standards are met.

Skills & Requirements

Must-have

  • Aseptic manufacturing experience
  • Quality systems knowledge
  • Regulatory compliance procedures
  • Product and material release decisions
  • Deviation management
  • Change control processes

Nice-to-have

  • Customer focus
  • Continuous improvement initiatives
  • Cross-functional collaboration
  • Supply chain understanding

Key Requirements

  • Degree or equivalent professional qualification in science/technical field
  • Significant GMP/GDP/GLP experience
  • Aseptic manufacture experience
  • Quality assurance role experience
  • Technical process understanding
  • Knowledge of quality systems
  • Awareness of regulatory interactions

Work Rights

Not specified

Tailored Resume

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