Project Process

SHAH DARSHAK JAYESHKUMAR

** ******** ** *** ******, NJ-08857 1-732-***-****

***************@*****.***

OBJECTIVE: To obtain a position in Pharmaceutical Manufacturing.

EDUCATION: Stevens Institute of Technology, Hoboken, NJ

Master of Science in Pharmaceutical Manufacturing, anticipated

Dec 2011 GPA: 3.22

Gujarat University, Vadodara, Gujarat, India

Bachelor of Science in Pharmacy May 2008

GPA: 3.90

EXPERIENCE: Mercury Laboratories Ltd, Vadodara, Gujarat, India

07/08 - 11/08

Regulatory Officer

. Prepared Dossier for the pharmaceutical product for its

registration in for Srilanka, Philippines, Africa (Nigeria)

according respective guidelines of the countries.

. Prepared the respective document and also design the

packaging design according to customer's expectation.

. Communicated with different departments for the respective

documents.

. Prepared inserts for the products and other regulatory

documents require for the registration.

Cadilla Pharmaceuticals Ltd Gujarat, India

10/07 - 11/07

Training (QA/QC/Production of Tablets and Capsules)

. To understand the roles and responsibility of QA, QC,

Production and gain and implement knowledge in an actual

industry.

. The testing and stability studies are carried in order to

know the pharmaceutical activity.

Gujarat Liqui Pharma Caps Ltd Gujarat, India

07/07 - 09/07

Training (QA/QC/Production of Soft Gelatin Capsules)

. To understand the roles and responsibility of QA, QC,

Production and gain and implement knowledge in a actual

industry.

. The testing and stability studies are carried in order to

know the pharmaceutical activity.

Sarabhai Ltd Gujarat, India

College trip to visit the production of active ingredients

through fermentation

. To understand the process involved in the production and also

the instruments used in the process.

Sunpharma Ltd Gujarat, India

. A trip to visit the instruments which are used in the

analytical testing of the product such as NMR and TLC.

SKILLS: Analytical skills: Titration, Chromatography, HPLC,

Spectroscopy; which Includes IR, UV, Fluorescence,

potentiometer, Qualitative and Quantitative Analysis of

Chemical compounds, Total organic count (TOC).

Computer skills: Microsoft Office, Minitab statistical

software, Ms Project,

PROJECTS:

. I have done research in the targeted drug delivery system (TDDS)

for treatment of breast cancer in Mumbai, India.

. The instruments for purification of water for injection (Double

Reverse Osmosis with Electro-deionization).

. User's requirement specification (URS) - "Equipment design for

its intended use in the process".

. Purification and concentration of protein from CHO cells by

tangential flow filtration (TFF).

. Made cookies; as an active entity for the treatment of a

Syndrome which was a part of project, to get familiar with the

actual scenario of the industry as well as the regulatory

aspects for the same. Since from the process development to the

production including the risk assessment of the same.

. "Going green" making the pharmaceutical process & its waste

environmental friendly.

EXTRA CURRICULAR ACTIVITIES:

. Member of ISPE (International Society of Pharmaceutical

Engineering).

. Participate in "Young innovator's choice competition-2008"-

Organized by Institute of Chemical Technology, University of

Mumbai.

. Winner of the Poster Presentation Competition on topic "Various

System of medicine" at the National Pharmacy Week, 2007

-celebrated in our college.

. Participated in Poster Presentation competition on the Topic of

"AIDS" at National Pharmacy Week-2006 celebrated in our

college.

. Third price in drawing competition held by -"World wide fund

for nature (WWF)" in school.

. Participate in Chess tournament in College and Inter College.

Reference: Available upon request.

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