VRUNDA PATEL

• Conduct detailed quality control (QC) reviews of clinical study documentation to ensure accuracy, completeness, and compliance with regulatory and organizational standards. • Maintain and review Trial Master File (TMF) documentation, ensuring proper filing, version control, and audit readiness. • Perform routine TMF quality checks to identify missing or incomplete documents and coordinate resolution with study teams. • Ensure study documents comply with approved templates, formatting standards, and regulatory requirements prior to publishing in document management systems. • Track and maintain documentation in clinical trial management and regulatory systems, ensuring timely updates and accuracy. • Generate study metrics and documentation reports to support internal quality reviews, audits, and regulatory inspections. • Collaborate with cross-functional teams and external vendors to track approvals and ensure completion of required documentation. • Support preparation of documentation and reports for audits, regulatory inspections, and internal quality assessments.

• Oversaw clinical trial activities to ensure adherence to study protocols, SOPs, and regulatory standards. • Conducted quality review of subject screening data and clinical documentation to confirm participant eligibility and protocol compliance. • Observed and monitored informed consent procedures, ensuring ethical standards and adequate decision time for study volunteers. • Coordinated with clinical teams to ensure accurate execution of dosing, subject monitoring, and study procedures. • Supervised collection, processing, and storage of biological samples to maintain sample integrity and traceability. • Performed routine quality checks on clinical operations, including vitals assessment, ECG monitoring, and clinical examinations. • Verified operational readiness of emergency medical equipment prior to study initiation. • Reviewed case report forms and source documents to ensure data accuracy, completeness, and regulatory compliance. • Identified protocol deviations or documentation gaps and worked with study teams to implement corrective actions. • Conducted periodic monitoring of clinical facilities and operational areas to ensure adherence to quality standards and proper documentation. • Maintained controlled study documentation, SOP logs, and study-related records for audit readiness. • Prepared monitoring reports and quality observations to support internal quality oversight. • Assisted in audit and inspection preparation, ensuring Trial Master File documentation was complete and accessible. • Collaborated with quality assurance teams, investigators, and project staff to address observations and maintain study compliance.

• Collaborated with cross-functional teams (QA, QC, and Production) to resolve quality issues and implement Corrective and Preventive Actions (CAPA) for continuous improvement. • Conducted dissolution testing, in-process quality checks, and inspections to ensure compliance with GMP and pharmaceutical regulatory standards. • Investigated deviations, non-conformances, and product complaints, performing root cause analysis (RCA) and implementing corrective actions. • Reviewed and maintained quality documentation, including batch manufacturing records, change controls, and quality reports, ensuring data integrity and traceability. • Ensured strict adherence to Standard Operating Procedures (SOPs), GMP guidelines, and internal quality management system (QMS) requirements. • Supported internal audits and quality reviews, contributing to continuous improvement and regulatory compliance within pharmaceutical manufacturing.