08/27/2025 updated
100 % available
Senior Clinical Quality Assurance Professional with 20+ Years Global Experience
Mumbai, India
Worldwide
Bachelor in PharmacyAuditingAudit ManagementAudit PlanningBusiness EfficiencyBusiness Process ImprovementCorrective and Preventive Action (CAPA)Clinical WorksPre-Clinical DevelopmentClinical ResearchComplianceData IntegrityGood Clinical Practices (GCP)Operational ExcellencePreventive ActionQuality Management
GCP/GLP Compliance
Expertise in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance across Phase I-IV and BA/BE trials, ensuring 100% site compliance and successful USFDA inspections with zero findings.
Regulatory Audit Management
Extensive experience leading global audits of investigator sites, preclinical facilities, clinical laboratories, and trial supply vendors across US, Europe, and Asia with proven track record in inspection readiness.
Quality Management Systems
Proficiency in developing and implementing quality management systems, SOP development, TMF remediation, and vendor oversight resulting in enhanced regulatory compliance and operational excellence.
Risk-Based Audit Management
Application of risk-based approaches to audit planning and execution, ensuring efficient resource allocation and focus on critical areas of compliance risk.
Process Improvement
Track record of optimizing quality processes, implementing corrective and preventative action plans (CAPA), and driving continuous improvement initiatives that enhance operational efficiency.
Training & Mentorship
Experience developing and delivering comprehensive training programs on GCP/GLP compliance, inspection readiness, and quality management for cross-functional teams.
Clinical Trial Integrity
Expertise in ensuring data integrity throughout clinical trials, including protocol review, informed consent verification, and comprehensive documentation management.
Expertise in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance across Phase I-IV and BA/BE trials, ensuring 100% site compliance and successful USFDA inspections with zero findings.
Regulatory Audit Management
Extensive experience leading global audits of investigator sites, preclinical facilities, clinical laboratories, and trial supply vendors across US, Europe, and Asia with proven track record in inspection readiness.
Quality Management Systems
Proficiency in developing and implementing quality management systems, SOP development, TMF remediation, and vendor oversight resulting in enhanced regulatory compliance and operational excellence.
Risk-Based Audit Management
Application of risk-based approaches to audit planning and execution, ensuring efficient resource allocation and focus on critical areas of compliance risk.
Process Improvement
Track record of optimizing quality processes, implementing corrective and preventative action plans (CAPA), and driving continuous improvement initiatives that enhance operational efficiency.
Training & Mentorship
Experience developing and delivering comprehensive training programs on GCP/GLP compliance, inspection readiness, and quality management for cross-functional teams.
Clinical Trial Integrity
Expertise in ensuring data integrity throughout clinical trials, including protocol review, informed consent verification, and comprehensive documentation management.
Experience
Professional experience10+ years
Freelancer since2025
Languages
EnglishFluent
Project history
Leading quality assurance for clinical trials, achieving 100% investigator site compliance and successful USFDA inspections with zero 483s. Transformed TMF quality from 65% to 98% accuracy and led external audits of vendors and service providers.
Implemented corrective actions from site audits ensuring seamless integration into products, resulting in flawless inspections. Achieved 40% cost savings through insourcing model and increased compliance to 90% by revamping CRO quality management systems.
Led inspection readiness for DCGI inspections, provided critical support during MHRA inspections, and ensured 100% accuracy in patient eligibility verification. Revitalized eLearning platform for GCP training, achieving 100% training compliance.