Kamal Kardani

"Rambha Nivas" Block- **, Giriraj Society No-3, Opp Amrut Palace

Junagadh, Gujarat 362002

Phone: +91-285-*******

Cell: +91-942-***-****, +91-957-***-****

E-Mail: ab1o1r@r.postjobfree.com, ab1o1r@r.postjobfree.com

Objective

I would like to utilize my skills to exchange my capabilities and to work in a progressive environment at a responsible and challenging position to add value to the company with my skills for the growth of the company where advancement and compensation are based on personal performance.

Core Qualifications

Reports generation and analysis

File/records maintenance

Computer proficient

Quick learner

Operations management

Results-oriented

Meticulous organizational skills.

Ability to manage priorities and meet deadlines.

Advanced problem-solving skills.

Having operating skills of HPLC, UV, HPTLC, GC, AAS like sophisticated instruments.

Documentation

Calibration of instruments.

SOP Preparation and Review

GMP & GLP.

preparation of dossier and compilation of guidelines for worldwide countries

Experience

June 2013 to July 2013

Vasu Healthcare Pvt. Ltd. Vadodara, Gujarat

Trainee- Regulatory Affair (International Business Development)

Responsible for planning, allocation, preparation & submissions of dossier for submissions to regulatory authorities with strictly working on deadlines to get marketing authorization.

Preparation, review and evaluation of documents for submission to regulatory authorities.

Preparation of Dossiers for Semi Regulated Market (EUCTD, ACTD, CTD & Country Specific) for Dosage forms as solid, liquid.

Submission of Regulatory documents for ASEAN Countries (Singapore, Philippines, Vietnam, Thailand, and Myanmar), CIS Countries (Ukraine, Russia, Uzbekistan, Turkmenistan, Kazakhstan, and Tajikistan) countries and European & MENA countries for registration of pharmaceutical products.

Responding queries received from various regulatory authorities.

Review of Process Validation , Master Manufacturing Documents, Specification and Standard Testing Procedure, Analytical Method Validation Report, Stability Studies.

Initiation of documents for COPP, FSC & licensing documents for Product approval.

Preparation of Documents regarding Sending Samples for Regulatory Overseas Countries for Registration Purpose.

Co-ordinate with QA, QC and Production Department at Manufacturing Sites.

September 2012 to May 2013

Vasu Research Centre Vadodara, Gujarat

Project Trainee- Analytical Development Lab

Worked on Analytical Method Development of Herbals Products on HPLC, HPTLC.

Compiled Guidelines for Registration of Herbal product Registration in Middle East and African Regions.

Education

2013 PG Department of Pharmaceutical Sciences- Sardar Patel University Vadodara, Gujarat

Master of Pharmacy Quality Assurance

Semester- IV - Distinction

Semester- III - Distinction

Semester- II - First Class

Semester-I - First Class

2011 C. U. Shah College of Pharmacy- Saurastra Univeristy Wadhwan, Surendranagar

Bachlor of Pharmacy General

Fourth Year - First Class

Third Year - First Class

Second Year - First Class

First Year - Second Class

2007 Alpha Highersecondary School Junagadh, Junagadh

H.S.C Higher Secondary Education

Distinction

2005 Nobel High School Junagadh, Junagadg

S.S.C Secondary Education

Honours

Professional Affiliations

Passed out the distance learning DL-101 general course on intellectual property held by World Intellectual Property Organization(WIPO).

State Level seminar on ???Calibration & Validation of Pharmaceutical Instruments, Equipment & Development of Methods??? at SSR College of Pharmacy, sponsored by Pune University, Silvasa on 3rd and 4th March, 2012.

National seminar on ???Nanotechnology in Drug Delivery: Emerging Trends & Advances??? at Department of Pharmaceutical Sciences, Sardar Patel University, sponsored by UGC, Vallabh Vidyanagar on 9th& 10th March, 2012.

National Workshop on ???Intellectual Property Rights & Patent System??? at Ramanbhai Patel College of Pharmacy, Charusat, sponsored by Gujarat Council on Science & Technology(GUJCOST),Changa on 23rd & 24th March 2012.

Passed out GPAT- an Entrance test For M.Pharm with Gujarat Rank 520. And AIR 3190.

IPC 009: Attended 61st Indian pharmaceutical congress held at Nirma University, Ahmadabad in Dec-2009 as a delegate.

Work History

January 2013 to Current

Vasu Healthcare Pvt. Ltd Vadodara, Gujarat

Trainee- Regulatory Affair (International Business Development)

Accomplishments

PUBLICATIONS

Kamal Kardani, Nilesh Gurav, Bhavna Solanki, Prateek Patel, Bhavna Patel., RP-HPLC Method Development and Validation of Gallic acid in Polyherbal Tablet Formulation. J App Pharm Sci, 2013; 3 (05): 037-042. Available online at http://www.japsonline.com/admin/php/uploads/894_pdf.pdf

2 more article is in progress.

PROJECT DETAILS

Recently finished my research project entitled, ???RP-HPLC Method development and validation of Gallic acid in Polyherbal Formulation???, at Vasu Research Centre, A division of Vasu Healthcare Pvt. Ltd., Vadodara, Gujarat.

Another Minor project entitled ???comprehensive review on regulatory situation and scope for herbal product registration in Middle East and North African Region???, carried out at Vasu Research Centre, A division of Vasu Healthcare Pvt. Ltd., Vadodara, Gujarat.

Interests

Research and Development

Bio-analytical Method Development

Analytical Method Development and Validation

Regulatory/Medical Affair

Quality Assurance

Personal Information

Date of Birth: 23rd of June, 1990

Present Resident in Vadodara, Gujarat, India

Sex: male

Status: Single

Hobbies: Travel, Music, Tennis, Cricket, Volley ball

Languages

Fluent reading/writing/Speaking English.

Fluent reading/writing/Speaking Hindi.

Fluent reading/writing/Speaking Gujarati.

References

Dr. D. K. Raval

IC/Head

PG Department of Pharmaceutical Sciences

Sardar Patel University

Vallabh vidyanagar, Guajart, India

Ms Kruti Pandya

Executive R&D

Vasu Research Center

Vadodara, Gujarat, India

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