- Manage inspection readiness planning and execution for GMP/GDP compliance.
- Oversee regulatory inspection preparation (FDA and global), including documentation and CMO coordination.
- Provide project management oversight—dashboards, timelines, and risk tracking.
- Support and guide CMOs through inspections and compliance activities.
- Rview and contribute to CAPAs, Change Controls, Deviations, and SOPs.
- Conduct Quality System checks and maintain inspection readiness documentation.
- Lead process improvements across quality and compliance functions.
- Dental insurance
- Health insurance
- Inspection Readiness: 5 years (Required)
- Project management: 2 years (Required)
- Small Molecule : 2 years (Required)
- Deviations: 2 years (Required)
- CAPA: 2 years (Required)
- Change Controls: 2 years (Required)
- GMP: 6 years (Required)
- global inspections: 2 years (Required)