Quality Advisor

Macclesfield

12 month secondment/FTC/FTO

Competitive salary and benefits

Take the responsibility to ensure our pipeline becomes a reality

In Quality, our work is important and valued. An unrivalled forward-looking approach, there’s no better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products – discovery, development and commercialisation.

Take the lead in ensuring the hard work from the rest of the business is realised, as we reliably get every medicine out to patients without challenge. We never give up in diligently ensuring our patients receive quality and safe medicines, responding to a large variety of, often complex, demands.

Macclesfield campus

The Macclesfield site is our second largest manufacturing site and the largest UK based campus, from which our medicines are manufacture, packaged and distributed to over 130 countries globally. People are at the very heart of AstraZeneca and the facilities around site support this. You will find an onsite gym, restaurants, parking, on-site holiday childcare and much more!

Quality Advisor role

We now have a Quality Advisor opportunity for a 12 month secondment/FTC/FTO, within our team.

The Quality Advisors are responsible for Quality and GMP compliance and decisions having an impact on AstraZeneca development projects and therefore AstraZeneca’s business and external reputation. They use risk management to evaluate compliance issues and to develop solutions.

The decisions are made against a background of regulations that vary depending on the stage of development and against a set of standards that require interpretation. They are responsible for QA release of Internal Drug Substance for clinical trials.

As a Quality Advisor, you will be responsible for assuring that activities and processes across the development chain are delivered to appropriate standards to meet regulatory expectations and assure product integrity and acceptability. You will interpret and trend compliance data to measure and improve quality standards.

As part of the team, you are expected to develop and maintain a knowledge of the quality regulations and guidelines applicable to your area and develop a deep scientific understanding of GMP assets and products you will be supporting.

Responsibilities

  • Provide Development Quality input into internal manufacturing activities for Drug Substance, including approval of manufacturing documentation

  • Provide Development Quality support of internal analytical testing, including support of instrument and equipment validation/qualification

  • Responsible for developing and approving GMP documentation and QA risk assessments and suggest mitigation activities and technical approaches to manufacturing for Drug Substance

  • Responsible for Development Quality release of internal manufactured Drug Substance for clinical trials

  • Provide advice to support the development, implementation and continuous improvement of GMP quality systems across the functions and support implementation of agreed global standards

  • Provide appropriate Quality Assurance input to business improvement projects

  • Provide support and guidance to functions to satisfy external Regulatory Authority GMP inspections

  • Responsible for QA approval of documentation related to manufacturing equipment and facilities to ensure GMP compliance, including maintenance, calibration, validation and change control.

Essential requirements

  • A relevant scientific degree (or the equivalent in experience) with experience of working in a GMP environment; preferably within a pharmaceutical development organisation

  • A broad and comprehensive understanding of Quality Systems and GMP is essential

  • An understanding of the pharmaceutical/drug development process

  • Good team working and networking skills and encourages team effectiveness

  • Demonstrates independent judgement and uses risk management

  • A good communicator with experience of interacting effectively across interfaces

  • Builds good relationships both internally and with external suppliers or service providers

Why AstraZeneca?

AstraZeneca has a big ambition with a clear strategy to get there. It’s a place to grow a fulfilling and exciting career with constant opportunities resulting from new products, technologies and growing areas like biologics. Our continued growth gives you greater exposure than anywhere else.

Next steps…

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

Applications are open from 6th September to 19th September 2021.

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