Senior Specialist Quality Assurance - 12 Month Secondment/FTC

Senior Specialist Quality Assurance – 12 Month Secondment/Fixed Term Contract

To provide QA expertise and support for manufacturing and packaging. To 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.

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

The role holder impacts directly on the value stream by influencing decisions through advice to others. They are responsible for the professional management of adverse events and all the associated quality management systems within the Process Execution Team (PET) they support.

The roles available are within the QA team which supports our aseptic manufacturing area, experience required is outlined below.

The role may be required to work a day shift pattern with 1 weekend in 6.

What you'll do:

You will be aligned to an aseptic manufacturing facility where you will 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'll 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.Provide 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.You will 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.Support the License to Operate processes within the aligned department, advising on deviations using professional discernment to make batch disposition recommendations to approve or reject a product.Assist in reviewing investigations to ensure root cause is established and appropriate countermeasures are in place and will support customer complaint investigations and approve investigation reports.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.

Essential skills and experience:

Degree or equivalent professional qualification in a science / technical field such as Pharmacy, Chemistry or BiologySignificant prior experience in Good Manufacturing / Good Distribution / Good Laboratory practice and/or compliance management. Aseptic manufacture experience is also required.Previous experience in a role aligned to quality assurance.A level of technical process understanding in manufacturing or packing or warehouse/distribution or Quality ControlKnowledge of and application of quality systems, including change control, deviation management and New Product IntroductionsAwareness / knowledge of regulatory interactions and compliance procedures and ability to apply this in an operations environmentHigh level of customer focus and strong ability to reinforce and maintain quality standards.

Desirable skills and experience:

Knowledge of other areas of the Supply Chain, including groups such as Regulatory, Global Quality, Manufacturing, Supply and Capability etc.Good understanding of the Quality Management Systems (QMS) with experience in managing and/or approving deviation, documentation and change controls.

So, whats next?

Are you already imagining yourself joining our team?

Good, because we cant wait to hear from you.

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.