- Manage deviations. Review and approve deviation documentation including investigations, root cause assessments, assignment of CAPAs, and deviation closure. Maintains deviation tracking database.
- Support regulatory audits.
- Review and approve records (change controls, test records, validations, protocols, etc.)
- Provide guidance and training related to Quality Assurance activities and compliance.
- Review GMP records to ensure compliance with SOPs and regulations.
- Maintain current Quality procedures.
- Serve as technical advisor as needed across manufacturing and quality departments
- Manage the complaint process including performance of complaint investigations and tracking of complaints to closure within the established time frames. Maintains the complaint database.
- Perform batch record reviews