Quality Assurance Associate

Location: Macclesfield

Competitive salary & benefits

Closing date: 16th September

Would you like to apply your expertise to impact Quality in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Be proud to play a critical role as the eyes and ears of our patients. Unafraid of the responsibility, we monitor and sign off each batch as if the medicine were for our own family. All our contributions add up to improving the quality of patients’ healthcare and ultimate their quality of life.

The Macclesfield site is our second largest manufacturing site and the largest UK based campus, from which our medicines are manufactured, packaged and distributed to over 130 countries globally. People are at the very heart of AstraZeneca and the facilities around site support this. You will find an onsite gym, restaurants, parking, on-site holiday childcare and much more!

The Quality Assurance team will support the design and build of a major new advanced sterile manufacturing facility taking the plant through to validated status and beneficial operation in 2024. It is a unique opportunity to be part of an integrated team working on all aspects of facility, equipment and process qualification and validation, on a plant that is at the forefront of design and technology. We are looking for 4 additional Quality Assurance Associates to join our team.

Working within the Sterile Manufacturing Project team you will interface with global engineering, Commissioning and Qualification (C&Q) and manufacturing teams to ensure successful project delivery. Cross functional working and collaboration are essential elements, providing guidance and support to ensure compliance with cGMP standards, product quality specifications and regulatory requirements.

You will also generate, review and approve related Qualification/ Validation and technical GMP documents and collate and interpret data such as quality key performance indicators, analytical results/trends.

What you'll do:

• Aligned to the Sterile Manufacturing area, you'll be required to reinforce the quality principles.

• Provide independent assurance of the maintenance of the appropriate quality standards within this area, whilst supporting timely and effective resolution of all quality issues to maintain the critical path of project timelines.

• You will be responsible for making decisions on data supporting commissioning, qualification and validation, participating in raw data reviews and quality approval of critical documents

• Being a Quality specialist, you'll provide leadership and support for internal and external inspection preparations resulting in successful regulatory submissions and approval, overseeing any actions to ensure ongoing compliance.

• Provide expert advice to the area on Good Manufacturing Practice/Good Development Practice/Good Distribution Practice / Good Laboratory Practice within the site, with reference to Good Manufacturing Practice guidelines and regulations.

• Use professional judgement to advise on deviations throughout the project lifecycle and assessment of impact.

• Ensuring compliance with change management processes within your area. You'll actively look for opportunities to identify and lead change and make efficiency savings, influence decisions and deliver results whilst ensuring compliance is maintained appropriately.

• Help deliver Manufacturing Excellence by participating in our Global Lean Framework.

Essential skills and experience required:

• Degree or equivalent professional qualification in a science / technical field such as Pharmacy, Chemistry or Biology.

• Have experience in working in a Quality Assurance role within the Pharmaceutical Industry.

• Significant experience in Good Manufacturing/Good Distribution/Good Laboratory practice and/or compliance management.

• Sterile Manufacturing Experience is helpful but not essential.

• A level of technical process understanding, commissioning, qualification and validation experience is desirable

• Knowledge of and application of quality systems, and be confident in the application of Quality Risk Management.

• Knowledge of Computer Validation, GAMP and how systems directly impact business processes throughout the pharmaceutical supply chain

• Awareness /knowledge of regulatory interactions and compliance procedures and ability to apply this in an operations environment.

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.

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.