Quality Assurance Officer – 12 month secondment/FTC

Macclesfield (UK)

As a Quality Assurance Officer, you will provide essential QA support for manufacturing, packaging, warehouse, distribution systems, and QC. Your role ensures that all manufacturing and testing processes meet regulatory and AstraZeneca standards, maintaining a high level of compliance while delivering efficient and reliable output. You will participate in quality initiatives and improvement projects to enhance compliance and reduce costs. Your expertise will directly impact the value stream by supporting and influencing decisions through your advice.

Accountabilities:

• Provide technical advice on good practices and manufacturing compliance, ensuring physical and environmental monitoring programs comply with current regulations.
• Assist in major failure investigations, ensuring recommendations are documented and action reports are completed within the timescale.
• Perform batch documentation review activities where appropriate.
• Support the complaints management process and respond to complaint investigations as needed.
• Complete GMP training within the PET.
• Maintain ongoing personal professional development.
• Provide out-of-hours cover for advice and assistance, ensuring manufacturing areas are not disrupted.
• Ensure plant readiness for internal and external audits and inspections.
• Support compliance of change management processes within the Process Execution Team.
• Contribute to the PQR process.
• Proactively identify opportunities for change and efficiency savings, influencing decisions while ensuring compliance.
• Support local and cross-functional change initiatives.
  
  
  

Essential Skills/Experience:

• Degree level or equivalent in a scientific discipline and experience of working in a GMP environment.
• Understanding of quality assurance and appreciation of other functions contributing to business objectives within a lean manufacturing environment.
• Willingness to work shifts as required by the business.
• Good knowledge of IT systems used by QAD.
• Knowledge of solids and aseptic packaging.
• Broad understanding of Supply Chain activities and processes.
• Ability to make complicated judgments within general operating guidelines.
• Knowledge of AstraZeneca Health & Safety SHEP’s applicable to the role at a competent capability level.
• Competent professional knowledge of current GMP requirements and regulatory processes.
• Foundation financial governance (fiscal awareness).
  
  
  

Desirable Skills/Experience:

• Good communication and influencing skills, including cultural awareness.
  
  
  

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, our work in Quality is both important and valued. We operate with an unrivaled forward-looking mindset, always innovating and trialing the latest models and technologies to improve reliability and excellence in our processes. As the voice of the patient, every batch we certify is a personal stamp of approval. Here, you'll feel empowered to step up, follow the science, and make decisions that put patients first. Our proactive, science-based approach drives us forward, ensuring we deliver what will have the biggest impact on our patients. Join a team where your contributions make a real difference.

Ready to take on this exciting challenge? Apply now!