Quality Assurance Training

Chintan H. Joshi

Present Address : C-**, Sawita Park,

Govindwadi, Isanpur,

Ahmedabad-382443

Gujarat, India

Contact No. : +91 - 990-***-****, 886-***-****

Email : **************@*****.***

Objective

I want to work in a learning and challenging environment with the use of my knowledge

to the best of my

abilities.

Area Of Interests

Analytical Research

Quality Assurance

Regulatory Affairs

Personal Particulars

Date of Birth : 20th August, 1989 Gender

: Male

Nationality : Indian

Marital Status : Unmarried

Hobbies : Music, Internet surfing, Playing Chess

Languages : Gujarati, Hindi, English

Educational Background

Higher Education

Post Graduation study : M. Pharm

Specialization : Quality Assurance

Institute / University : S K Patel College of Pharmacy/Ganpat university

Grade : Distinction (7.62 CGPA)

Post Graduation study : MBA (persuing 2013-2015)

Specialization : TQM

Institute / University : Sikkim Manipal University

Graduation study : B. Pharm

Institute / University : L M College of Pharmacy/Gujarat university

Grade : First Class (64.21 %)

School Education

Board : Gujarat Secondary & Higher Secondary Education Board (GSEB / GHSEB)

S.S.C (10th) : 87.71 % Year : March 2004

H.S.C (12th) : 91.00 % Year : March 2006

GUJCAT : Marks obtained 107.75/119

Industrial Training

Mann Pharmaceuticals Year : 2010

Dept. : QA & QC

Academic Project

Title: Development & validation of various analytical methods for simultaneous

estimation of Rosuvastatin calcium & clopidogrel bisulphate in capsule dosage form.

Stability indicating HPLC method

Simultaneous equation method (UV)

Q Absorption ration method (UV)

Dissolution

Organization: Torrent Research Centre (Bhat)

Duration : July 2011 to Dec 2011

Responsibilities :

Analytical method development

Analytical method Validation

Forced degradation study

Drug-Excipient compatibility study

Analytical method transfer

Analytical method development for cleaning procedure

Seminar/ Workshop

Pharma Vision 2020, New Delhi (IPC), 2008

UGC Sponsored National Seminar On Recent Advances In Analytical Techniques For

Pharmaceutical, Vallabh Vidyanagar, 2011

UGC Sponsored National Seminar On Bioavailability & bioequivalence, Ganpat

Vidyanagar, 2011

Pharma Vision 2020, Bangalore (IPC), 2011

UGC Sponsored National Seminar On Advances in Chromatography, Ganpat Vidyanagar,

2012

Professional Experience

Total Experience : 2.5 Years

Designation: QA Officer (Duration: Sep 2013 to till date)

Company : Astra life care

Analytical method validation protocol preparation & review of data

Stability study sample planning (bracketing & matrixing), review of results

STP, Specifications, COA preparation & review

Literature survey for method development

Hands on experience on analysis of FP, RM, In process, Stability sample

Preparation of process validation protocol & review of analytical data

Hands on experience for Cleaning validation & hold time study

To perform Annual Product Review of products to assure that quality standards are

appropriate.

Hands on experience of operating & calibration of HPLC (shimadzu, waters),

Dissolution,

UV spectrophotometer, Karl fisher

Designation: QA/QC Officer (Duration: Jan 2012 to Sep 2013)

Company : Halewood Laboratories Pvt. Ltd

Responsibilities :

In Process Quality checks at various stage

BMR preparation & issue

Process validation protocol preparation & sampling

CTD preparation for product registration

Maintaining stability study planning & summary

Finish product analysis (HPLC)

Review of analytical worksheet, TAD & COA

Faced out of specification & audit

Preparation of audit compliance report

Maintaining Reference & working standard record.

Computer Skill

Knowledge of all editions of windows & MS Office, Internet, Pharmasuite Software.

I hereby declare that the information given herewith is correct to my knowledge and I

will responsible for any discrepancy.

Chintan H. Joshi

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