Vikas Kurhade Email & Phone Number | Audit (CAPAs & Deviation) management, Risk Management/Assessment, Project Audit readiness, IQMS Auditing, PSMF Quality Check, Pre-Sales Consultant & PV ICSR processing.  As QA Lead: • Performing Data Analysis and responsible to publish monthly compliance dashboards related to CAPA/Findings/Deviation deliverables (Excel & PowerPoint) • Support in Global Quality Risk Management/Assessment activities in all aspects of coordination/facilitations of meetings, dashboard preparation & presentation and continuous improvement. • Coordinate with Client stakeholders for effective tracking of assigned CAPAs/Deviations. • Contribute to Audit related findings & CAPA and Deviation Management implementation and documentation by completing all required processes in TrackWise database. • Well versed with IQMS audits as an Auditee and Auditor (scheduling, conduct, release/draft audit report, approve CAPA responses & track CAPA actions till closure). • Supporting the Global QPPV office in managing the PSMF in line with the relevant Client processes by quality check of assigned PSMF Quality sections & respective annexes.  Business Development (as Pre-Sales Analyst): • Working closely with the management team on proposals and pitches for business. • Attending meetings with business development managers and acting as a technical expert. • Replying to customers following requests for information and proposal requests (RFI & RFP). • Knowledge of pricing calculation and give the best solution to the business development managers. • Responsible for keeping presentation material (PowerPoint & Word) looking fresh and technically up to date.  As Team Leader: • Strong team-building skills. • Able to effectively assess operational inefficiencies. • Exceptionally talented at devising appropriate goals. • Good knowledge of measurable tasks. • Competent at social, oral and written communication. • Excellent goal tracking and report writing.  As Drug Safety Associate (ICSR): • Performing duplicate search, booking the case & Data entry into Client’s corporate safety database, e.g. ARISg & Argus by validating the source document form. • Retrieving the cases by generating the appropriate work list. • Narrative writing • Performing validity assessment for all cases and determining the seriousness of the events. • Generating follow up letters if required. Types of Cases Processed: • Clinical Trial Cases. • Legal Cases • Spontaneous Cases • PMS Cases • Diploma Certification in Data Science.  Power BI  Python  My SQL  Machine Learning  Statistics  R Programing

Vikas Kurhade

Audit (CAPAs & Deviation) management, Risk Management/Assessment, Project Audit readiness, IQMS Audi...
Uran, Uran, India

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Vikas Kurhade’s Email vikas.kurhade@cognizant.com

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Vikas Kurhade’s Location Uran, Uran, India

Vikas Kurhade’s Current Industry Tata Consultancy Services

Vikas Kurhade’s Prior Industry Cognizant Technology Solutions

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Work Experience

Tata Consultancy Services

Quality Assurance Team Lead

2015-09-01 00:00:00 - Present

Cognizant Technology Solutions

Junior Data Analyst

2012-05-01 00:00:00 - 2015-09-01 00:00:00

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FAQ About Vikas Kurhade

Vikas Kurhade is located at
Uran, Uran, India

Vikas Kurhade is a Audit (CAPAs & Deviation) management, Risk Management/Assessment, Project Audit readiness, IQMS Auditing, PSMF Quality Check, Pre-Sales Consultant & PV ICSR processing.  As QA Lead: • Performing Data Analysis and responsible to publish monthly compliance dashboards related to CAPA/Findings/Deviation deliverables (Excel & PowerPoint) • Support in Global Quality Risk Management/Assessment activities in all aspects of coordination/facilitations of meetings, dashboard preparation & presentation and continuous improvement. • Coordinate with Client stakeholders for effective tracking of assigned CAPAs/Deviations. • Contribute to Audit related findings & CAPA and Deviation Management implementation and documentation by completing all required processes in TrackWise database. • Well versed with IQMS audits as an Auditee and Auditor (scheduling, conduct, release/draft audit report, approve CAPA responses & track CAPA actions till closure). • Supporting the Global QPPV office in managing the PSMF in line with the relevant Client processes by quality check of assigned PSMF Quality sections & respective annexes.  Business Development (as Pre-Sales Analyst): • Working closely with the management team on proposals and pitches for business. • Attending meetings with business development managers and acting as a technical expert. • Replying to customers following requests for information and proposal requests (RFI & RFP). • Knowledge of pricing calculation and give the best solution to the business development managers. • Responsible for keeping presentation material (PowerPoint & Word) looking fresh and technically up to date.  As Team Leader: • Strong team-building skills. • Able to effectively assess operational inefficiencies. • Exceptionally talented at devising appropriate goals. • Good knowledge of measurable tasks. • Competent at social, oral and written communication. • Excellent goal tracking and report writing.  As Drug Safety Associate (ICSR): • Performing duplicate search, booking the case & Data entry into Client’s corporate safety database, e.g. ARISg & Argus by validating the source document form. • Retrieving the cases by generating the appropriate work list. • Narrative writing • Performing validity assessment for all cases and determining the seriousness of the events. • Generating follow up letters if required. Types of Cases Processed: • Clinical Trial Cases. • Legal Cases • Spontaneous Cases • PMS Cases • Diploma Certification in Data Science.  Power BI  Python  My SQL  Machine Learning  Statistics  R Programing