QA Technical Specialist

Are you a Quality specialist, with experience in biologicals, looking for your next move? Do you have a passion for delivering technical solutions? AstraZeneca might be for you!

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

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.

Business area

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. The Quality Technical Specialist 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

As the technical specialist, you will 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.

The role will 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

Why AstraZeneca

Join an environment of excellence, where we’re backed by a belief that good can always be better. It means we search for opportunities to add value – harnessing science and evidence to foresee risk. A place to continuously innovate to find new and better ways to ensure we are improving outcomes for patients.

Next steps

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Applications are open from 16th April to 30th April 2021.

Competitive salary and benefits

Where can I find out more

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

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