Quality Assurance Associate

Quality Assurance Associate

Macclesfield campus

Be the voice of the patient

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.

Here you’ll feel empowered to step up, follow the science and evidence to make decisions that put patients first.

Site description

The Macclesfield site is our second largest manufacturing site and the largest UK based campus, from which our medicines are manufacture, 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!

Business area

The Quality Assurance team supports the manufacturing function and this team in particular support the steriles area. We have an excellent opportunity for a Quality Assurance Associate to join our team based at our Macclesfield campus on a 12 month secondment/FTC.

Working within the packing and sold dose manufacturing area, you will support the business area ensuring all products released for sale or further processing comply with cGMP standards, product quality specifications and regulatory requirements.

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

The role

Aligned to the Formulation and Packing area, you’ll be required to reinforce the quality principles. You will also 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 product flow across the factory.

You will be responsible for making product and material release decisions, operating within global standard pack ahead of clearance (PAOC) and ship ahead of clearance (SAOC) guidelines.

Being a Quality specialist, you will provide leadership and support for internal and external inspection preparations as well as significant audits to aid in developing improvement plans, you will oversee 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.

Advising on deviations using professional discernment to make batch disposition recommendations to approve or reject a product.

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.

You’ll help deliver Manufacturing Excellence by participating in our Global Lean Framework.

Essential skills

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

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

  • A level of technical process understanding in manufacturing or packing or warehouse/distribution

  • Knowledge of and application of quality systems, including change control, deviation management and New Product Introductions

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

**Please note that the role does require the successful candidate to work 1 in 4 weekends**

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.

Next steps

Are you ready to bring new ideas and fresh thinking to the table? Excellent! We have one seat available and we hope it’s yours.

Applications are open from 14th to 31st May 2021

Competitive salary and benefits

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