Quality Advisor - Clinical Supply Quality
Macclesfield (UK)
Introduction to role
Join us at AstraZeneca as a Quality Advisor in our Operations team. Be the voice of the patient and play a critical role in monitoring and signing off each batch of medicine as if it were for your own family. Your contributions will directly improve the quality of patients' healthcare and their quality of life.
Accountabilities
As a Quality Advisor, you will be responsible for QA release of Drug Substance and Investigational Medicinal Product for clinical trials. You will provide Dev Q input to support Packaging, Labelling & Distribution of IMP as required. You will also support the delivery of QA activities for your assigned portfolio of projects. Your role will involve providing advice to support the development, implementation and continuous improvement of GMP quality systems across the development functions and support implementation of agreed global standards.
You will interpret, trend and report compliance data, to measure and improve quality standards within the development functions. Lastly, you will provide appropriate Quality Assurance input to business improvement projects.
Essential Skills/Experience
- Appropriate scientific degree with significant years of experience of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organisation
- A broad understanding of Quality Systems and GMP is essential
- An understanding of the pharmaceutical/drug development process
Desirable Skills/Experience
- Good team working and networking skills and encourages team effectiveness
- Demonstrates independent judgement and uses risk management
- Capable of making decisions, acting courageously and communicating with conviction and inspiration
- A good communicator with experience of interacting effectively across interfaces
- Builds good relationships both internally and with external suppliers or service providers
- Demonstrate drive and energy in the role to make a difference.
- Demonstrates a high degree of personal credibility
- Experience of computerised systems validation or other validation/qualification activities
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 crucial and highly valued. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. Here, you'll feel empowered to step up, follow the science, and make decisions that put patients first. Our proactive, science-based approach ensures that we deliver what will have the biggest impact on our patients. Working on an immensely rich pipeline, we adapt to get new medicines out quicker while maintaining a sharp focus on patient-centricity.
Ready to make a difference? Apply now to join our team!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.