Quality Advisor - Clinical Supply Quality

Location: Macclesfield

Competitive salary and benefits

Do you have expertise in, and a passion for Clinical Supply Quality? Would you like to apply your expertise to make an impact in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

Make a more meaningful impact to patients’ lives around the globe

Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

Business area

Clinical Supply Quality is responsible for compliance decisions that have an impact on AstraZeneca Clinical supplies and therefore AstraZeneca’s business and external reputation. We use risk management to evaluate compliance issues and to develop solutions, decisions are made against a background of regulations.

What you’ll do

As a Quality Advisor in Macclesfield, you will work with supply chain teams and be accountable for Development Quality release of externally manufactured Drug Substance, Drug Product and Investigational Medicinal Product for clinical trials.

When working with Clinical Supply functions, the Quality Adviser is expected to assure that activities and processes across the development chain are delivered to appropriate standards to meet regulatory expectations and assure product integrity and acceptability. The ability to interpret and trend compliance data to measure and improve quality standards is key.

Operating as part of a global organisation with an integrated approach to build an organisation with common processes and ways of working you will also provide quality advice and input to:

• Support the development, implementation and continuous improvement of Good Manufacturing Practice (GMP) quality systems across the functions and support implementation of agreed global standards

• Support external activities for Packaging, Labelling & Distribution of Investigation Medicinal Product

• Investigate complaints associated with clinical products

In addition, you will provide support and guidance to satisfy external Regulatory Authority GMP inspections, provide appropriate Quality Assurance input to business improvement projects and support Issue Management Teams on specific issues.

Essential skills for the role

• Appropriate scientific degree with experience of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organisation

• A broad and comprehensive understanding of Quality Systems and GMP

• Grounded knowledge of the pharmaceutical/drug development process

• Good knowledge in the Quality Assurance (QA) arena and specifically in GMP matters

• Good team working and networking skills, encourages team efficiency

• Demonstrates independent judgement and uses risk management, capable of making courageous decisions, and communicating with conviction and inspiration

• A good communicator, interacts effectively across interfaces, builds positive relationships both internally and with external suppliers or service providers

• Demands excellence and delivers whilst demonstrating a high degree of personal credibility

Why AstraZeneca

It’s a place to grow a fulfilling and exciting career with constant opportunities resulting from new products, technologies and growing areas like biologics. Our continued growth gives you greater exposure than anywhere else.

Applications are open from 10th September to 25th September 2021.

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date Posted

Closing Date

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.