- Develop, review, and manage standard operating procedures (SOP’s) ensuring conformance with local and international requirements.
- Assure the effectiveness of the quality management system for clinical trials, pharmacovigilance, and regulatory affairs.
- Conduct GxP audits according to client agreements and internal programs.
- Manage vendors’ quality assessments and audits.
- Coordinate activities during regulatory GCP and GVP inspections and manage corrective/preventive action plans.
- Complete and manage quality management system documentation and accountability forms.
- Identify non-compliances, discuss audit findings, and provide recommendations for process improvement.
- Assist in root-cause analysis to identify effective corrective actions.
- Participate in staff training regarding quality and legal requirements.
GCPQuality Assurance