Audit Support requirements:
1. Facilitate audit request process for GP regulatory inspections, customer audits, and internal quality audits
* Develop a strong understanding of Abbie's SLand system evidence to support audits
* Leverage available resources and improve resources to enhance or maintain with changes in environment.
* Coordinate audit support activities with appropriate Abbie system SMEs to tutfilt audit requests; escalate risks and issues, to ensure timely resolution/responses in alignment with agreed SLAs.
* Build relationships with system SMEs to facilitate the audit support process
* Engage in ongoing dialogue with compliance team to identity and obtain alignment on process improvements.
* Drive implementation of process improvements:
* Streamine data collection of audit requests, propose and implement smartsheet updates to minimize site data input white ensuring appropriate data is captured for beneticial analytics
* Review lessons learned to identity challenges and reduce cycle times o identity opportunities to increase self-service portal usage.
2.Execute mock audit activities, as requested, to enable inspection readiness.
Build data analytics and perform analysis on audit data:
* Faudit request data
* internal quality audit observations
externat inspection data, including observations and warning letters, using available sources, e.g.Redica
identity potential gaps/remediation needs; establish cadence and format to share insights o improvement opportunities (proactively addressing gaps based on regulatory insights); frame
opportunities for consideration by appropriate Quality System CoE
propose continuous improvement (Ci) initiatives and execute initiatives to completion
4. Maintain self-service portat tinks, ensuring current evidence is published.
5. Continuous Improvement
* Use technology, automation, and Alto implement enhancements to audit request platform and audit sell-service capabilities
* Monitor feedback and propose expansion of capabilities and improvements
6. Status Reporting
Provide weekly status reporting
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