QA Technical Specialist

QA Technical Specialist

Speke

Pioneer a ‘new’ Quality way

As the voice of the patient, every batch we certify is a personal stamp of approval. Not something we take lightly, we are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes.

We are a team of ambitious people, who want to go far, and we’re all here to achieve. It’s what drives us to be proactive and solutions-focused. At every stage of production, we step up and take accountability to deliver, each of us feeling responsible for the outcomes.

We now have an opportunity to join our team as a QA Technical Specialist. Working at our biologics site in Speke, reporting into the Quality Technical Manager; you will support functions across research, development, quality control, engineering, manufacturing and supply chain.

You will be part of the Quality Technical team delivering the Quality Strategy and Goals; realising solutions based on data, risk and regulatory compliance.

What you’ll do

Provide expertise across Quality processes supporting operations at the Speke Site, including Equipment/Material/Method/Process/Product Introduction, Supplier and Site Change, Major GMP/License deviation investigations, Risk Management, Regulatory Governance/Compliance and Quality Risk Management/Control Strategy Application.

Provide technical support to realise lean, compliant solutions based upon data, technical understanding and regulatory intelligence; enhancing capabilities and compliance.

Experience in supplier management, change control governance and quality risk management is preferable, as well as validation lifecycle/documentation, GMP/license compliance and self-inspection/regulatory audits.

We are looking for candidates with a keen interest in application of lean tools and establishment/maturity of business processes to drive lean, compliant delivery of operations; supporting introduction of digital solutions and working inclusively and collaboratively across the site functions.

Essential for the role

• Degree in a relevant subject or the equivalent in experience

• Proven pharmaceutical industry experience in manufacturing, QC, or QA validation of biologics

• Established QA technical expertise

• Membership of a professional body eg ISPE, PDA, IOB, RSC etc

• Broad understanding and up to date knowledge of cGMP regulation and guidelines

• Knowledge and understanding of Quality systems such as Qualification/Validation, Change Management and Quality Risk Management

So, what’s next…

Are you already imagining yourself in this role? Good, because we can’t 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.