Pavithra Rajan

• Independently authored and signed off on 400+ GLP-compliant preclinical study reports with 100% OTD - zero
missed deadlines across all final reports
• Maintained 99% OTD for protocol distribution, ensuring zero compliance gaps with ICH E6(R3), FDA 21 CFR, OECD
GLP, UK GLP, and MOHAP-aligned regulatory standards
• Administered Veeva Vault (EDMS) for document control, audit trails, TMF/ISF maintenance, and regulatory
submissions across concurrent studies
• Coordinated study timelines with cross-functional teams (Study Directors, Scientists, QA, Bioanalytical) ensuring
protocol adherence and on-time sponsor deliverables
• Applied CAPA processes to resolve data discrepancies; developed SOPs via SharePoint improving team efficiency
and GLP audit readiness
• Managed CTMS for study planning, scheduling, and resource tracking; leveraged Power BI (Microsoft Certified)
and Advanced Excel for metrics dashboards

• Assisted in fermentation process development for statin production; investigated effects of temperature, pH, and
nutrient levels on yield and implemented process improvements

• Supported production and QC of RT-PCR kits for COVID-19 detection; conducted component testing and
maintained GMP-compliant production records