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Vaishnavi Naik Gaunkar

@vaishnavinaikgaunkar

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MBA candidate in Operations Management with 2 years’ QA/QC in IVD, driving compliance and improvement.

India

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What I'm looking for

I’m seeking a dynamic role where I can combine IVD QC expertise with Operations Management to drive continuous improvement, ensure regulatory-compliant quality, and deliver measurable operational efficiency gains.

I’m an MBA candidate specializing in Operations Management, with two years of experience as a Quality Control Officer in the In Vitro Diagnostics (IVD) industry. I focused on ensuring product quality and regulatory compliance—supported by preparation for WHO audits—while driving process improvements to strengthen operational efficiency.

In my QC role, I performed inspection and diagnostic kit testing in line with STPs, SOPs, GLP, ISO 13485, and QMS standards, using tools like PCR Thermocyclers, UV Spectrophotometers, and Conductometers. I developed and implemented STP for clinical sample preparation for 30+ diagnostic assays, maintained audit-ready QC documentation (including SAP-based QC data entry and batch traceability), and supported calibration/validation, troubleshooting, and real-time and accelerated stability testing. I also mentored new team members and collaborated cross-functionally to keep testing workflows quality-compliant.

Experience

Work history, roles, and key accomplishments

Logistics Intern

Capricorn Logistics

Dec 2025 - Mar 2026 (3 months)

Gained exposure to air and sea import-export freight forwarding and customs operations, including trade documentation and Incoterms. Supported warehouse inward and dispatch workflows, maintained inventory updates using Excel and PYROPS (WMS), and analyzed warehouse layout/visual management to identify process improvement opportunities.

Trade Documentation Customs Compliance Incoterms Dispatch Coordination Inventory Management Excel PYROPS (WMS)

Quality Control Officer

Molbio Diagnostics Pvt. Ltd.

Sep 2022 - Jul 2024 (1 year 10 months)

Ensured IVD product quality and regulatory compliance by performing incoming, in-process, and finished testing in line with STPs, SOPs, GLP, ISO 13485, and QMS. Developed STP for clinical sample preparation covering 30+ diagnostic assays, maintained QC documentation/batch records in SAP, and supported stability testing, equipment calibration/validation, OOS, and change control.

ISO 13485 GLP PCR Thermocyclers Stability Testing Documentation Control

Quality Control Apprentice

Molbio Diagnostics Pvt. Ltd.

Jun 2022 - Sep 2022 (3 months)

Supported routine QC testing and documentation in a regulated environment, focusing on SOP adherence and audit readiness to strengthen compliance and quality practices.

Audit Readiness In Process Testing Regulatory Compliance Team Collaboration

Microbiology QC Intern

Zydus Cadila Healthcare Limited

May 2018 - Present (8 years 1 month)

Performed hands-on microbiology QC activities including media preparation, autoclaving, microbial testing, endotoxin testing, environmental monitoring, and sterility testing to strengthen industrial compliance knowledge.

Media Preparation Microbial Testing Environmental Monitoring Sterility Compliance Quality & Compliance

Education

Degrees, certifications, and relevant coursework

Agnel Institute of Engineering and Management

Master of Business Administration (MBA), Operations Management

2024 - 2026

Grade: 90.6% (Sem III); Ranked 3 in First Year

Activities and societies: Student Coordinator (Data Nexus, Business Analytics Club); Placement Committee Member; Academic Representative (BLINC MBA Student’s Council); Event Coordinator (Techlegion, AITD Event); Valedictory Function Coordinator (Nexus, MBA Event).

MBA in Operations at Agnel Institute of Engineering and Management (Assagao, Goa) for 2024–2026, with 90.6% in Sem III and a rank of 3 in the first year.