Abirami Paraman

QA analyst Complaints - Monitor @ Alcon

About

A competent professional with 6 years of experience in Post Market Surveillance (PMS) of Risk Managements process, Medical device reporting, Vigilance reporting and Complaint Investigation of Medical Device Domain Industry. Possesses profound practical and theoretical knowledge about the best practices of CAPA, Root cause analysis techniques, trend analysis of complaints. Specialist in DFMEA and PFMEA review, medical record review, scientific literature review and MedWatch form review. Exposure in standard such as ISO 13485 Medical Quality Management System and ISO 14971 Risk Management application, Regulation such as 21CFR 820, Part 803, Part 806 and EU MDR (2017/745). Experience in Trackwise, PowerBI, JDE tools and Salesforce.

Country

India

City

Chennai

Industry

Medical Device

Skill

MDRs, Regulatory Compliance, Product Compliance, Security Protocols, Microsoft Office, Salesforce.com, Medical Records, Quality Investigations, Quality Procedures, ISO 14971, Biotechnology, Product Complaints, Clinical Documentation Systems, Interviewing Subject Matter Experts, TrackWise, Corrective and Preventive Action (CAPA), Risk Management, Spanish, Quality Inspection, Process Quality Improvement

Experience

QA analyst Complaints - Monitor

Alcon

2024-1 - Present · 2 yrs 9 mos

Banglore

Perform activities that ensure required quality and safety standards are being met for our products. Management of customer complaints including documentation, logging on through iTrack, investigation and root cause analysis, associated corrective actions and preventative actions (CAPA) activities, tracking, trending and reporting. Implementation of local quality systems that comply with standards and regulatory requirements.

Quality Assurance Analyst

Alcon Laboratories (India) Private Limited

2024-1 - Present · 2 yrs 9 mos

Managed the entire complaint lifecycle, including documentation, logging via iTrack, conducting investigations, performing root cause analysis, and implementing Corrective and Preventative Actions (CAPA). Investigated 5,000+ customer complaints across diverse product categories, including Lens Care Products and Pharma Surgical Instruments, ensuring compliance with quality and safety standards. Received the Pinnacle Performer Award for excellence in quality assurance, complaint investigation, and process improvement. Conducted inspections of returned complaint samples, Pulled and inspected retained samples to support investigations and quality assessments. Authored comprehensive quality summaries based on investigation outcomes, ensuring clarity, accuracy, and regulatory compliance.