Quality Advisor – IT

Quality Advisor – IT

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!

The role

The Quality Advisors are responsible for Quality and GMP compliance and decisions having an impact on AZ development projects and therefore AZ’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.

When working with functions they are 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. They interpret and trend compliance data to measure and improve quality standards.

The role holders are expected to develop and maintain a knowledge of the quality regulations and guidelines applicable to their area and be developing a deep scientific understanding of GMP assets and products they are supporting.

Accountabilities/Responsibilities

  • Provide Development Quality input the review and approval of computerised system validation documentation and data.

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

  • Responsible for developing and approving GMP documentation.

  • 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.

  • Support Issue Management Teams on specific issues.

  • Operate as part of a global organisation with an integrated mentality to create an organisation with common processes and ways of working.

  • Drives, role models and supports a strong lean culture that promotes standardisation, simplification and continuous improvement

Essential skills

  • Degree-level education with experience of validation of computer systems used within a GMP environment.

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

  • Good knowledge and reputation in the Quality arena and specifically in GMP matters

  • Capable of making decisions, acting courageously and communicating with conviction and inspiration

  • 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 13th to 26t September… Apply now!

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