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Audit Compliance and Data Lead at AstraZeneca

Posted in Other 30+ days ago.

Location: Wilmington, Illinois





Job Description:

Working as a member of our Quality Compliance team you will work collaboratively with our globally based auditors and stakeholders. You will help us manage our Quality Management Systems with a primary focus on driving data and systems excellence.


What you will do:


Drive a culture of continuous improvement with a 'can do' attitude. Engage with auditors, IT and stakeholders to identify and deliver improvements and simplifications.


Support the development and delivery of the Audit Data Strategy. Work with the audit teams and IT to ensure requirements of GQA associated teams (GQA Audit, Self-Inspection and External Inspection) are met.


Enable the visualization of quality data to support the identification, analysis and interpretation of data trends or patterns to facilitate decision making.


Act as Enterprise Quality Vault (EQV) Audit process and system expert supporting the role out of new releases.


Support GQA use of other EQV systems including the Enterprise Content Management System (ECMS). Support the generation, review and approval process for audit procedures within ECMS.


Support the training and documentation related to EQV data ensuring consistent audit application and driving capability uplift.


Essential for the role:


  • Appropriate scientific degree

  • 5 years experience working within a pharmaceutical GMP environment

  • Demonstrated knowledge of trending data analytics and visualization tools

  • Ability to draw conclusions from data and communicate succinctly to partners

  • Ability to convey complex information with confidence

  • Embraces and demonstrates a diversity and inclusion approach and role models these behaviors for the organization.

  • Excellent communication (written and verbal) skills and the ability to build effective working relationships.

Desirable


  • Experience with auditing in a GMP environment

  • Experience leading improvement and change programs

  • Project management experience



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.


AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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