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.

We have roles available in both our Non-sterile formulation and Packing team and Zoladex QA team, experience required is outlined below.

The Non-sterile role will be required to work shifts, 2-week pattern, Monday to Friday 7-3 and 1-9. The Sterile role will be required to work a day shift pattern with 1 weekend in 6.

What you'll do:

• You will be aligned to either the Formulation or Packing area 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 Biology
• Significant prior experience in Good Manufacturing / Good Distribution / Good Laboratory practice and/or compliance management. For the role in Zoladex, prior experience in sterile manufacture is 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 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
• High 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, what’s next?

Are you already imagining yourself joining our team?

Good, because we can’t wait to hear from you.

Date Posted

04-Feb-2025

Closing Date

18-Feb-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.