Quality Assurance Officer

Quality Assurance Officer

18-month Secondment/Fixed Term Contract

A standard day shift pattern is in place for this role

Macclesfield

At AstraZeneca, we’re not afraid to do things differently. We’re building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening up new ways to work, pioneering cutting edge methods and bringing unexpected teams together.

At AstraZeneca every one of our employees makes a difference to patient lives every day. You may not feel you’re at the frontline of research but your role in changing patients’ lives is critical. Our mission is ambitious and it takes the skills of a collaborative team to really deliver on what science can do.

We have fantastic opportunity within our Quality Assurance Department (QAD) for a Quality Assurance Officer (QAO) to support the sterile manufacturing facilities based at our Macclesfield campus!

You will ensure that the manufacture and/or testing and operation of support systems meet all the regulatory and AstraZeneca standards and the appropriate level of compliance. This service must be delivered as efficiently as possible whilst still maintaining a reliable and robust output.

You will participate in quality initiatives and improvement projects to deliver enhanced compliance at a reduced cost.

The QAO impacts directly on the value stream by supporting and influencing decisions through advice to others. They are responsible for providing Quality Assurance support to an assigned area.

Key Responsibilities:

  • Provides technical advice on their area of expertise, good practice and impact on procedures /manufacturing compliance including, where appropriate, ensuring the physical and environmental monitoring programme is maintained in compliance with current regulations

  • Assists in major failure investigations ensuring recommendations are made and documented and action report is completed within the timescale

  • Where appropriate, perform batch documentation review activities

  • Support complaints management process and where appropriate respond to complaint investigations

  • Complete GMP training within the business area

  • Maintain ongoing personal professional development

  • Where required provides an agreed level of out of hours cover for advice and assistance including an agreed level of cover for inter-related roles to ensure manufacturing area is not disrupted e.g. release of components

  • Ensure plant readiness for internal and external audits and inspections

  • Support the compliance of the change management processes within the Process Execution Team

Essential skills and experience:

  • Degree level or equivalent in a scientific discipline and experience of working in a GMP environment

  • An understanding of quality assurance, as well as an appreciation of other functions and how they contribute to achieving the objectives of the business within a lean manufacturing environment

  • There may be a requirement to work shifts in this role as required by the business

  • Good knowledge of IT systems used by QAD

  • Knowledge of solids, aseptic packaging.

  • Broad understanding of Supply Chain activities and processes

  • Ability to make complicated judgements, within general operating guidelines

  • Knowledge of AstraZeneca Health & Safety SHEP’s applicable to role at the competent capability level.

  • Competent to professional knowledge of current GMP requirements and regulatory processes

  • Foundation financial governance (fiscal awareness)

  • Good communication and influencing skills including cultural awareness

Why AstraZeneca?

We are active players in growth and evolution. It’s a clear long-term strategy and we see the role we play. There’s a great opportunity to influence how we develop supply chains, promoting a Lean mindset and leading on sustainability.

Next steps..

If you are interested and are searching for your next exciting role, submit your CV and cover letter and apply today!

Competitive salary and benefits package

Applications are welcome from 30th June to 14th July 2021

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