Job Description

Specialist Quality Assurance - 12 Month Secondment/FTC
Speke
Pioneer a 'new' Quality way
As the voice of the patient, every batch we certify is a personal stamp of approval. Not something we take lightly, we are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes.
As QA Specialist you will act as a subject matter expert within QA providing technical and analytical support to the Quality Assurance function within the Speke site in addition to the wider site and global AZ partners. You will be responsible for the management and execution of quality documentation, compliance and quality system business processed within the quality technical department.
We'll look to you to bring a focus on innovation, digital uplift, new technologies and sustainability practices across the documentation lifecycle as well as an expert knowledge and understanding of Good Manufacturing Practice.
What you'll do:
You will lead by example as a quality professional, supporting continuous improvement and compliance across key documentation and business processes. Your responsibilities include driving LEAN and digital initiatives, utilising process improvement tools, ensuring alignment with AZ standards, and proactively managing quality risks. You will coach others, share best practices, and help uplift capabilities across teams. You'll also partner with cross-functional teams to meet documentation and compliance requirements, deliver efficient guidance, and actively contribute to regulatory and self-inspections.
Essential Skills & Experience:

• Qualified to degree level / or equivalent in a scientific discipline
• Experience in a Biopharmaceutical/pharmaceutical industry
• Experience in a cGMP environment (Quality assurance, Quality Control or Validation)
• Demonstrated knowledge on quality systems
• Excellent technical writing and communication abilities
• To be able to author standard GxP documentation independently
• An understanding of the overall drug development and commercialization process from development, launch and through life cycle management
• Project Management and Influencing skills
• Demonstrated ability to work cross-functionally and to solve complex problems
• Act as BPO for quality documentation and compliance and provide BPO oversite and management e.g. training, PMR and continuous improvement

So, what's next...
Are you already imagining yourself in this role? Good, because we can't wait to hear from you!
Date Posted 26-Jun-2025
Closing Date 06-Jul-2025
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.