Description
SUMMARY * 20+ years of experience in Quality Management and continuous improvement of quality, within Drug Safety, Clinical, Manufacturing, Regulatory Compliance and R &D domains of Bio-Pharmaceuticals * Conducted risk based Investigator site global audits including contract global central clinical labs * Conducted and Managed CRO's, 3rd party vendors / service providers for GCP and GvP compliance * Supported Internal and external corporate and health authority inspections including FDA * Managed remediation and corrective action plans for clinical trials (Risk Based Monitoring) are conducted in compliance with ICH E6 R2 requirements and other applicable guidelines * Ensured clinical data quality, integrity, data privacy and security of global GCP systems * Managed Change Control, Customer Complaints, Deviation Management and CAPAs * Conducted internal audit on corporate policies, procedures, clinical systems including eTMF * Implemented QMS and led Quality Management, coordination, and Subject Matter Expertise for core Quality Programs to ensure GCP compliance was maintained while delivering Quality services
Accomplishments
Highlights:
Keywords
