Services include:
- Develop and oversee a full quality management system for GxP activities as well as and maintain QA and GxP compliance programs and infrastructure, including document control/change control processes, internal/external audits, deviations, review and tracking investigations and CAPAs
- Review master and executed batch record documentation to include package and labeling specifications
- Audits of CMOs and CSV audits
- In partnership with SMEs, establish quality procedures, and standards by which all employees abide by
- Review and approve CMO/CTL documentation
- Manage training programs for overseeing or performing GxP activities and serve as an in-house advisor on GxP compliance
