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Work Experience

July 2022 - Present

March 2021 - July 2022

Astam Diagnostics

NULIFE, Noida

July 2022 - Present

Quality Assurance Executive

Nulife is a privately held company specializing in the manufacturing of medical diagnostic devices and IVD (In Vitro Diagnostics) products located in Noida, Uttar Pradesh. Nulife focuses on the production of a wide range of Class C and D Rapid Diagnostics products, leveraging cutting-edge immuno-chromatography technology. The product portfolio includes Lateral Flow Tests for critical conditions such as Typhoid, Malaria, HBsAg, HIV, HCV, Syphilis, Drug of Abuse Tests, Toxoplasma, COVID-19 (Ag & Ab). In addition to rapid diagnostics, Nulife has expanded its expertise to include ELISA kits, catering to the growing demand for accurate and sensitive diagnostic tools in clinical and research settings. The company prides itself on maintaining the highest standards of quality and compliance, holding ISO 9001, GMP, FDA, CE and ISO 13485 certifications. 

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Roles and Responsibilities:

  • Handling Customer Complaints

  • Calibration and Preventive Maintenance of equipment, instruments and MMDs as per schedule 

  • Handling Customer audits, Regulatory audits and Internal audits

  • Validation of various corrugated boxes

  • Deviation (Planned / Unplanned Deviation)

  • Prepared Annual Product Quality Report (APQR) of Products

  • Non-Conformance 

  • Temperature Mapping and Monitoring

  • Maintenance and documentation of all quality related records

  • Correction, Root Cause Analysis and CAPA

  • 7 QC Tools

  • Change Control 

  • Risk Assessment 

  • Post Market Surveillance (PMS) 

  • Training of employees as per training calendar 

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Key Achievements :

  • Handled ANVISA (Agência Nacional de Vigilância Sanitária) audit for export of COVID-19 Antigen Rapid Tests in the year June, 2023

  • Handled CDSCO audit for manufacturing license of Malaria Pf/Pan in the year December, 2023

ASTAM DIAGNOSTICS Pvt. Ltd, Rajasthan

Mar 2021 - July 2022

Quality Assurance (QA) Executive

Astam Diagnostics Private Limited is a privately held company located at Bhiwadi, Rajasthan. The company is involved in manufacturing of Medical Devices (Thermometer/BP meter) and IVD-Medical Devices/Rapid Range products (Lateral Flow Tests based on Immuno-chromatography). Presently manufacturing various Class B, C and D Rapid Diagnostics products such as HcG, Typhoid, Ovulation, Malaria, HBsAg, HIV, HCV, and Syphilis products. Company has ISO:9001 and ISO:13485 certification.


Roles and Responsibilities:

  • Preparation and review of various technical documents such as SOP, Device Master File, Analytical Method Validation Protocol, Standard Testing Procedure and MFRs.

  • Conduct internal quality audits and follow up the finding

  • Corrective and Preventive Action (CAPA) and RCA

  • 7 QC Tools

  • Management Review Meeting (MRM)

  • Change Control (CC)

  • IPQA

  • 5S 

  • Handling Non-Conformance

  • Review Real Time stability and Accelerated stability as per schedule

  • Calibration of equipment/instruments as per planner

  • Review of artwork/designs​


Key Achievements :

  • Handled ISO 13485:2016 audit for manufacturing license as per the norms leading to greater efficiency, productivity and improvement in various aspects of Medical Devices.

  • Handled CDSCO audit for manufacturing license of Class - C and Class D rapid diagnostics test products (HBsAg, HIV, Syphilis, HCV, and Syphilis)​

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