Quality Assurance Associate

Quality Assurance Associate (QAA)

18 month secondment/FTC

Location: Macclesfield

Competitive salary & benefits

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!

The role

Aligned to the Sourcing and Supply QA team, 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.

In addition to QAA activities outlined below, this role within Sourcing & Supply QA provides line management to a team of approximately 10 QA Support Officers. The team plays a pivotal role in Macclesfield Operations covering a range of activities including: Management of the Site Archive, QA Inspection and Release of Printed Packaging Components, Sampling and identification of Incoming Goods (including API’s and Formulated Product), and execution of the Pack Change QA check.

The role gives a great insight into different areas of the manufacturing process and the job holder requires to build strong working relationships with customers across the factory and the wider global supply chain. The abilities to prioritise, communicate effectively, and work flexibly are all pivotal to the successful execution of the role as is providing inspiring leadership and motivation to the team. The job holder will be an experienced Lean Cross Functional Enabler and act as role model to the team itself.

Responsibilities:

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.

Other duties include:

  • Responsible for making product and material release decisions, operating within global standard pack ahead of clearance (PAOC) and ship ahead of clearance (SAOC) guidelines

  • Providing leadership and support for internal and external inspection preparations as well as significant audits to aid in developing improvement plans, you will monitor 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

  • Advise 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:

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

  • Experience of managing a team

  • 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 or Quality Control

  • 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

  • Knowledge of other areas of the Supply Chain, including groups such as regulatory, Global Quality, Manufacturing, Supply and Capability etc.

  • Experience of working in a Lean environment, and knowledge of Lean principles and tools would be of benefit, but not crucial

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…

Applications are welcome by 5th December 2021.

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