Job Description
Responsibilities:
- Facilitate audit request process for GxP regulatory inspections, customer audits, and internal quality audits.
- Develop a strong understanding of SLC and 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 system SMEs to fulfill 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 identify and obtain alignment on process improvements.
- Drive implementation of process improvements.
- Streamline data collection of audit requests, propose and implement Smartsheet updates to minimiz...