Quality Assurance Associate

Quality Assurance Associate

Location: Macclesfield

Competitive salary & benefits

Closing date: 21st November

Build a long-term career by unlocking opportunities for lifelong learning

Build unrivalled capabilities in a place that promotes learning agility and offers development opportunities. We never stand still so you’ll have the chance to constantly grow your abilities, skills and knowledge. Here we are a fusion of challenging and interesting work, in an energising and inspiring environment.

Make a meaningful impact on people’s lives with life-changing medicines

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society.

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 3 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.

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