Jayesh Makwana
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Jayesh Makwana Email & Phone Number

Deputy Manager at Amneal Pharmaceuticals
Location: Ahmedabad, Gujarat, India 8 work roles 4 schools
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Current company
Amneal Pharmaceuticals
Role
Deputy Manager
Location
Ahmedabad, Gujarat, India
Company size
6651 employees

Who is Jayesh Makwana? Overview

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Quick answer

Jayesh Makwana is listed as Deputy Manager at Amneal Pharmaceuticals, a with 6651 employees, based in Ahmedabad, Gujarat, India. AeroLeads shows a matched LinkedIn profile for Jayesh Makwana.

Jayesh Makwana previously worked as Assistant Manager at Amneal Pharmaceuticals and Clinical Manager at Veeda Clinical Research. Jayesh Makwana holds B.Pharmacy, Pharmacy from Gujarat University.

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Amneal Pharmaceuticals

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Profile bio

About Jayesh Makwana

As being GCP and GPV Auditor following task done-Protocol and it's essential documents review-In process audit-System and vendor audit-Site selection and Site close out visit-Clinical Site sponsor monitoring for oncology studies-Specific CRF and it's study specific form desing and preparation-Retrospective raw data review-Clinical Study report review-Assist in IMP supplies to different clinical sites-Specific oncology trial training conduct to Site team-Reviewing pharmacokinetics and statistic raw data and it's report along with CDISC output .- Auditing of Pharmacovigilance activity such as ICSR, PADER, PSUR , PV database etc .- Review and respond regulatory as well as Sponsor queries.

Current workplace

Jayesh Makwana's current company

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Amneal Pharmaceuticals
Amneal Pharmaceuticals
Deputy Manager
Ahmedabad, GJ, IN
Website
amneal.com
Employees
6651
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8 roles

Jayesh Makwana work experience

A career timeline built from the work history available for this profile.

Associate Scientist

Veeda Clinical Research

Ahmedabad, Gujarat, India

-Manage QA deliverables. -Protocol review of different dosage and different guidelines -Departmental SOP review -Review regulatory and sponsor query -Auditing pharmacovigilance activities -Preparing DCGI Application for BABE facility approval /renewal. -Performing System /vendor audit

Apr 2020 - Apr 2021

Senior Research Associate

Veeda Clinical Research(Official)

Ahmedabad, Gujarat, India

GCP and GPV Auditor 1.Performing In-house Bio studies Audit in adherence of Regulatory guidance,SOP and Study Protocol2.Performing System Audit and Facility Audit3.Responding Sponsor as well as Regulatory Queries4.Performing trend analysis within System and identify critical incident and escalate to the Management and follow up to the resolves.5.Retrospective clinical raw data review6.Review of Standard operation procedure of 7.Different Departments in view of Regulatory requirements and current system.8.Review Study Protocol, ICF and CRF in adherence of Regulatory guidelines.9.Final Study Report review as per ICH E3 requirements10.Performing vendor Audit as per Company contract and in adherence of Agreement and basic Regulatory requirements.11. Review Pk stat raw data ,it's report and CDISC output.12.Delegate and Managing QA deliverables as per study timeline.13. Assist sponsor in facility round and to the inspector in regulatory inspection.14. Auditing of Pharmacovigilance department .

Jul 2017 - Mar 2020

Officer

Sun Pharma

Vadodara, Gujarat, India

Clinical trial protocol ,ICF review. Inprocess audit activity.CRF designing and review.Site selection, site monitoring.Raw data review.Clinical report review.Ensure ICH GCP compliance.Clinical investigational product supply to clinical site.Tanning to study staff.System audit, vendor audit.

Jul 2014 - Dec 2016

Junior Research Associate

Cliantha Research Limited

Ahmedabad, Gujarat, India

Clinical Quality Assurance

Sep 2012 - Jul 2014
Team & coworkers

Colleagues at Amneal Pharmaceuticals

Other employees you can reach at amneal.com. View company contacts for 6651 employees →

JB Justin Becker Justin Becker Colleague at Amneal PharmaceuticalsAtlanta Metropolitan Area, United States View → KJ Kunal Jangale Kunal Jangale Colleague at Amneal PharmaceuticalsAhmedabad, Gujarat, India View → EJ Eden Jenkins Eden Jenkins Colleague at Amneal PharmaceuticalsRaleigh, North Carolina, United States View → SP Solanki Pradipkumar Baldevbhai Solanki Pradipkumar Baldevbhai Colleague at Amneal PharmaceuticalsAhmedabad, Gujarat, India View → MC Mudi Chandra Reddy Mudi Chandra Reddy Colleague at Amneal PharmaceuticalsPodalakur, Andhra Pradesh, India View → RS Ryan Schneider Ryan Schneider Colleague at Amneal PharmaceuticalsSan Marcos, California, United States View → NR Nitu Rawal Nitu Rawal Colleague at Amneal PharmaceuticalsMorganville, New Jersey, United States View → MR Mauricio Ramirez Mauricio Ramirez Colleague at Amneal PharmaceuticalsHauppauge, New York, United States View → BS Bhavesh Shah Bhavesh Shah Colleague at Amneal PharmaceuticalsAhmedabad, Gujarat, India View → GP Gunjan Patel Gunjan Patel Colleague at Amneal PharmaceuticalsPiscataway, New Jersey, United States View →
4 education records

Jayesh Makwana education

B.Pharmacy, Pharmacy

Gujarat University

Post Graduate Diploma In Clinical Research, Clinical Research

Focus Educare

Base Sas, Clinical Software

Epoch

D.Pharma, Pharmacy

Gujarat University
FAQ

Frequently asked questions about Jayesh Makwana

Quick answers generated from the profile data available on this page.

What company does Jayesh Makwana work for?

Jayesh Makwana works for Amneal Pharmaceuticals.

What is Jayesh Makwana's role at Amneal Pharmaceuticals?

Jayesh Makwana is listed as Deputy Manager at Amneal Pharmaceuticals.

Where is Jayesh Makwana based?

Jayesh Makwana is based in Ahmedabad, Gujarat, India while working with Amneal Pharmaceuticals.

What companies has Jayesh Makwana worked for?

Jayesh Makwana has worked for Amneal Pharmaceuticals, Veeda Clinical Research, Veeda Clinical Research(Official), Jubilant Life Sciences Ltd., and Sun Pharma.

Who are Jayesh Makwana's colleagues at Amneal Pharmaceuticals?

Jayesh Makwana's colleagues at Amneal Pharmaceuticals include Justin Becker, Kunal Jangale, Eden Jenkins, Solanki Pradipkumar Baldevbhai, and Mudi Chandra Reddy.

How can I contact Jayesh Makwana?

You can use AeroLeads to view verified contact signals for Jayesh Makwana at Amneal Pharmaceuticals, including work email, phone, and LinkedIn data when available.

What schools did Jayesh Makwana attend?

Jayesh Makwana holds B.Pharmacy, Pharmacy from Gujarat University.

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