Sushmita Kundu

• Support pre-audit and inspection preparations by assisting teams and reviewing essential documents to ensure readiness. Involve in drafting response of pre-audit and during audit requests.
• Provide onsite and remote support as required, facilitating seamless operations during audits and inspections.
• Lead project teams in investigating root causes of quality issues, employing analytical skills to drive effective solutions.
• Facilitate development of robust Corrective and Preventive Actions (CAPA), ensuring alignment with quality standards and regulatory requirements.
• Review audit and inspection responses prior to final Quality Assurance (QA) review, ensuring completeness and accuracy.
• Contribute to resolution of critical issues by offering expert-quality advice and strategic direction to project teams.
• Assist in compiling quality metrics and compliance metrics based on review and identifying quality trends.
• Experience in quality management system for documenting deviation and quality events/quality issues.
• Experience in TrackWise and Veeva quality management system. Working closely with client/ project team members with respect to any deviation, CAPA, child CAPA, and effectiveness check.
• Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary.
• Involve in document review/SOP review process during initiation of project. Collaborate with cross-functional teams to gather necessary documentation and provide insights for effective project planning.
• Compile and maintain Pharmacovigilance System Master File (PSMF), ensuring compliance with regulatory requirements and internal standards.

• Involved in Quality review of Literature cases, SUSAR Clinical trial cases, Spontaneous Drug and Vaccine cases.
• Also involved in handling of case allocation, case prioritization, training and mentoring of new associates.
• Involved in identification and management of duplicate ICSRs.
• Assisted in quality review of different types of cases for US based Client which includes spontaneous, health authority and partner cases in client safety database.
• Performed registration of initial and follow up information for cases in safety database.
• Performed case import activities of initial and follow up cases
• Performed Lateness documentation form activity (LDF) along with obtaining of Root cause analysis (RCA) and Corrective and Preventive action plan (CAPA) for late cases.

• Worked on the classification of Clinical research documents according to the type of document.
• Assisted for quality control of the processed documents for validation purpose.
• Led the Electronic native format submission process.
• Performed QC checks for the validation of the data.
• Led the process of ENF submission- for ensuring the batch registration, Pre-QC and Image QC for the process of e-TMF documents registration.
• Monitored overall functioning of processes ensuring compliance to the agreed SLA levels. Enlightening awareness about process through training sessions and discussions with the process teams.
• Managed and mentored the team of 12 members in vertical level and project level by conducting team huddles and sharing.
• Managed multiple tasks simultaneously, ensuring timely completion of all assignments.
• Participated in regular team meetings, contributing valuable insights toward process enhancements.

• Worked on classification of Clinical research documents according to the type of document.
• Assisted for quality control of processed documents for validation purpose.
• Led Electronic native format submission process.
• Performed QC checks for validation of data.
• Monitored overall functioning of processes ensuring compliance to agreed SLA levels. Enlightening awareness about process through training sessions and discussions with process teams.
• Managed and mentored team of 12 members in vertical level and project level by conducting team huddles and sharing.