# Jitesh Rathod

Jitesh Rathod is a remote worker on Himalayas, Quality Specialist (CAPA Writer) at IQVIA RDS (India) Pvt. Ltd., based in India.

Source: https://himalayas.app/@jiteshrathod

```text
Quality Specialist at IQVIA RDS, investigating clinical-trial quality issues and developing CAPAs.
```

| Detail | Value |
| --- | --- |
| Availability | Open to opportunities |
| Location | India |
| Authorized to work in | India |
| Salary expectations | 30k+ USD |
| Job categories | Quality Specialist |
| Skills | Clinical Quality Management, Quality Management Systems, Corrective And Preventive Actions (CAPA), Root Cause Analysis, Clinical Trial Audit, GxP Compliance, ICH GCP, Audit And Inspection, Audit Planning, Deviation Management, Change Control, Clinical Trial Management, Clinical Operations, Clinical Research, Clinical Trial Monitoring |
| LinkedIn | https://linkedin.com/in/jitesh-rathod-b-pharma-pgpfsrl-mba-ccrp-40b585128 |

## About

```text
At IQVIA RDS (India) Pvt. Ltd., I investigate deviations, non-compliance, quality issues, potential serious breaches, and customer complaints for Eli Lilly and cFSP Boehringer Ingelheim. I perform root cause analysis and develop, implement, and monitor CAPAs.

At COD Research Pvt. Ltd., I oversaw the Quality Management System and planned and conducted audits across investigator sites, systems, strategic partners, and vendors. I also reviewed study documents for compliance and supported sponsor and regulatory audits.

At Veeda Clinical Research Ltd., I conducted GxP, site, vendor, alliance, and system audits, and supported investigation reviews and trend analysis. My work there was recognized with an innovation award and a key contribution award.

Earlier, I supported clinical trial coordination, operations, and literature research at organizations including Larvol LLC, Meril Lifesciences Pvt. Ltd., and Lambda Therapeutic Research Pvt. Ltd. I hold an MBA/PGDBM in Operation Management and a Bachelor of Pharmacy, and I’m willing to relocate and travel.
```

## Experience

### Quality Specialist (CAPA Writer) (current)

[IQVIA RDS (India) Pvt. Ltd.](https://himalayas.app/companies/iqvia). Aug 2025 - Present

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Lead investigations into deviations, non-compliance, and quality issues, performing root cause analysis and developing CAPAs. Maintain eQMS, ensure GxP compliance, and coach junior quality specialists.
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Skills: CAPA, Root-Cause-Analysis, EQMS, GxP, ICH-GCP, ISO, FDA, EMA, Quality-Management, Documentation, Trend-Analysis, Coaching

### Assistant Clinical Manager (Auditor)

COD Research Pvt. Ltd.. Apr 2023 - Jul 2025

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Oversaw the Quality Management System, including SOPs, document control, change control, and ISO audits. Developed and executed audit plans, conducted investigator site, system, and vendor audits, and mentored junior QA auditors.
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Skills: Quality-Management-Systems, SOP-Management, Document-Control, Change-Control, ISO-Auditing, Audit-Planning, Investigator-Site-Audits, Supplier-Audits, ICH-GCP, Risk-Assessment, Mentorship

### Deputy Clinical Manager (Auditor)

Veeda Clinical Research Ltd.. Jan 2021 - Apr 2023

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Conducted quality checks and performed system, site, vendor, alliance, and GxP audits. Managed audit planning, reporting, and CAPA closure, and facilitated sponsor audits and regulatory inspections.
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Skills: Quality-Assurance, Audit, GxP, CAPA, Change-Control, Deviation-Management, Trend-Analysis, Regulatory-Inspections, Software-Validation

### Analyst/Contractor

[Larvol LLC](https://himalayas.app/companies/larvol). Jul 2020 - Jan 2021

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Performed literature research for disease/therapeutic areas, searching patent and company websites to identify developments. Analyzed and summarized clinical trial information from registries and news sources.
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Skills: literature-review, Clinical-Trials, PubMed, Data-Analysis, Summarization

### Clinical Research Associate

Meril Lifesciences Pvt. Ltd.. Feb 2020 - Jun 2020

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Monitored clinical trials at sites, selected investigators, and liaised with doctors. Verified investigator training and protocol compliance, and coordinated clinical studies.
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Skills: Clinical-Monitoring, Site-management, Investigation-Selection, Protocol-Compliance, Clinical-Studies

### Clinical Trial Assistant

Lambda Therapeutic Research Pvt. Ltd.. Mar 2018 - Feb 2020

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Assisted clinical teams with documentation, site identification, and feasibility studies. Managed EC submissions and prepared site budgets and clinical trial agreements.
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Skills: Clinical-Documentation, Site-Identification, feasibility-studies, EC-Submissions, Budgeting, Clinical-Trial-Agreements

### ETMF Specialist

Syntel Pvt. Ltd.. Feb 2017 - Feb 2018

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Managed global trial master file quality for sponsor and CRO studies. Imported clinical documents into CREDI system and maintained study trackers.
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Skills: TMF, ETMF, Credi, Document-Management, Clinical-Trials, Data-Imports

### Project Coordinator

ClinAarc Pvt. Ltd.. Sep 2016 - Jan 2017

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Executed clinical strategy at sites, overseeing patient recruitment and site support. Reviewed clinical data and provided training to site staff.
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Skills: Clinical-Operations, Site-management, Patient-Recruitment, data-review, Training

### Research Coordinator

Government Medical College and Hospital. Jan 2015 - Aug 2016

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Coordinated daily clinical trial activities, ensured staff credentialing, and managed data collection and reporting. Participated in site visits and sponsor audits.
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Skills: Clinical-Trials, Data-Collection, AE-SAE-Reporting, Site-visits, Sponsor-And-Regulatory-Audits

## Education

### NMIMS University

MBA/PGDBM, Operations Management. Grade: I

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Pursued an MBA/PGDBM in Operations Management, graduating in 2021.
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### RTM Nagpur University

PGP, Forensic Science and Related Law. Grade: I

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Completed a Postgraduate Program in Forensic Science and Related Law in 2015.
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### RTM Nagpur University

Bachelor of Pharmacy, Pharmacy. Grade: II

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Earned a Bachelor of Pharmacy degree in 2013.
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### MSBTE

Diploma, Pharmacy. Grade: I

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Completed a Diploma in Pharmacy in 2009.
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## Tech stack

- Ema

To contact Jitesh, message them from this profile with a Himalayas employer account: [Hire on Himalayas](https://himalayas.app/hire).

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