At AstraZeneca, we’re not afraid to do things differently. We’re building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening up new ways to work, pioneering groundbreaking methods and bringing unexpected teams together.

At AstraZeneca every one of our employees makes a difference to patient lives every day. You may not feel you're at the frontline of research but your role in changing patients' lives is essential. Our mission is ambitious and it takes the skills of a collaborative team to really deliver on what science can do.

We have a fantastic opportunity for a Quality Assurance System Support Officer to join the team!

You'll be responsible for maintaining master data for QAD within ICON, GQCLims, eLab, Empower, EM, WebCoA, CIMS and eWM and you will coordinate key QAD documentation to approval efficiently within Quality Assurance Department with the aim of maintaining compliance with quality standards.

Responsibilities:

• Maintain material masters for all materials and specifications and quality standards using ICON and GQCLims. This will include timely response to requests for data in support of investigations/reports.
• Technical support (first line) for ICON, GQCLims and eLab, Empower, EM, WebCoA, CIMS and eWM.
• Coordinate the issue of certificates of analysis to global customers and perform QA product release activities as delegated by the QP.
• Identify change and make efficiency savings whilst ensuring an appropriate level of compliance.
• With a real passion for detail, you will ensure that specific activities are kept up to date in readiness for internal and external audits and inspections.

Essential skills and experience:

• Experience of working within a GMP environment, you will have a comprehensive understanding of how the quality assurance function operates. This will be coupled with an understanding of other business functions and how they contribute to achieving the objectives of the business within a lean manufacturing environment.
• Experience in quality assurance review / approval / release of key quality compliance documents
• Experienced with IT systems used by QAD and you will know how to maintain/update data in master templates.
• Solid understanding of current GMP requirements and regulatory processes
• Foundation financial governance (fiscal awareness)

Date Posted

Closing Date

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.