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Anjisnu Dhar

@anjisnudhar

Message

I investigate medical device complaints, strengthen compliance, and improve patient-focused quality operations.

India

Message

What I'm looking for

I’m looking to deepen my ownership in medical device vigilance, quality, or pharmacovigilance roles where I can improve investigation processes, support compliance, use data to drive decisions, and grow into leadership responsibilities.

At Wipro, I manage end-to-end investigations for Class II and III diagnostic and therapeutic medical device complaints under FDA 21 CFR Part 820. I reduced a 5,000-case backlog by 20% in one month and closed approximately 300 complaints within 48 hours during a critical KPI period.

I bring a pharmacy background and hands-on quality experience spanning DHR reviews, CatsWeb QMS documentation, audits, CAPA, dashboard metrics, and new-hire training. I’m focused on strengthening Materiovigilance through accurate investigations, data-driven decisions, and continuous improvement.

Experience

Work history, roles, and key accomplishments

Current

Medical Device Complaint Investigator

Current

Wipro Limited

Aug 2025 - Present (1 year 1 month)

Manages end-to-end complaint investigations for Class II and III medical devices, ensuring compliance with FDA 21 CFR Part 820. Reduced departmental backlog by 20% and maintained 99% documentation accuracy in CatsWeb QMS.

21 CFR 820 Complaint Investigation DHR Review CatsWeb QMS Salesforce Microsoft 365 Quality Audits CAPA Process Optimization team training

Intern

Aurio Pharma Laboratories Pvt. Ltd.

Aug 2024 - Sep 2024 (1 month)

Gained exposure to Quality Control and Quality Assurance procedures, including In-Process Quality Control protocols and SOPs. Assisted in packaging finished products and identifying potential defects.

Quality Control Quality Assurance SOPs