Quality Control Manufacturing

Shreya Patel

*** ****** ***** ****, ******, NJ **837 * Cell # 732-***-**** * Email #

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

OBJECTIVE

Seeking a challenging opportunity that allows me to contribute my knowledge

and Experience in

The Pharmaceutical /clinical research industry towards helping my employers

achieve their

Desired goals.

EDUCATION

> Master of Science - Pharmacology and Toxicology,

May '09

A & M College of Pharmacy, Long Island University, Brooklyn, NY

> Bachelor of Pharmaceutical Science,

Jun '06

Dr. D.Y. Patil College of Pharmacy, Pune University, India

PROFESSIONAL EXPERIENCE

> Twilight Litaka Pharma Limited, Pune, India Jan

'06 - Dec '06

QA Associate

Task:

. Working knowledge of cGMP, GLP; Preparation of qualification

program for all instruments, preparation and implementation of

Analyst validation program.

. Performed in-process quality control checks during manufacturing

and thus ensured the product compliance as per the specification

. Ensured the cleanliness of the manufacturing area, equipments and

thus provided the line clearance before the manufacturing

operation.

. Preparation and implementation of effective SOPs and batch records

thus ensured procedures are followed accordingly and documented

properly.

. Data Review (Protocols, Instrument calibration and usage Records,

Daily and Monthly Backup of Instrument).

. Preparation and implementation of System, User and Backup/Archival

Guidelines for all instruments using in Quality Control as per

21CFR.

ACADEMIC EXPERIENCE

> Ardor Drugs Pvt. Limited, Vadodara, India Jun

'05 - Dec '05

Internship

Tasks:

. Involved in the functioning and basics of manufacturing area, the

standard processes and control guidelines of Good Manufacturing

Practices.

. Oversaw manufacturing and troubleshooting in production of tablets

and soft gelatin capsules. Loading drugs or devices; monitoring

packaging operation for Soft Gelatin Capsule.

. Processing of gelatin and standard procedure for gelatin capsule

formation with guidelines to follow blister packing

. Reviewed various documents like, the batch manufacturing records,

results of the in-process quality control checks, certificate of

analysis, packaging material specification

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> Long Island University, Brooklyn, NY Sept

'08 - Dec '08

Project Work

. Project Title : Metastasis of Brain Tumor/Cancer VS Polyphenols

(Bioflavonoid)

Literature review on Types of Brain Tumor, Polyphenol-Synthesis and

Regulation, Inhibition of Carcinogenesis by Polyphenol, Current

treatment with polyphenols available in clinical trails For

Carcinogenesis

COURSE WORK

> Biostatistics

Measures of central tendency, variability, and standardization,

concepts of probability and sampling; techniques of estimation, and

statistical tests for hypothesis-testing

> Toxicology of Drugs and Chemical

Toxicity at organ level (liver, kidney, heart, brain, immune system),

apoptosis, necrosis, carcinogenesis.

> Experimental in Pharmacology & Toxicology

ELISA, Serum Chemistry (ALT, CK, BUN), Gel Electrophoresis (Southern

Blot), DNA- extraction, Spectrophotometer, HPLC, GCMS, TLC.

> Advanced Pharmacology

Pharmacokinetics-I (Entry, distribution and elimination of drugs),

Pharmacokinetics-II (Time- course of drug action), Pharmacogenomics.

PRESENTATIONS

> Long Island University

Southern blotting Technique and its clinical application

BCL-2 gene family and its role in Apoptosis

Vaccines and therapeutic antibodies-Nicotine Vaccine

> Dr.D.Y Patil College of Pharmacy

Introduction and working principle of CVS with examples of agents that

alters ventricular fibrillation

SKILLS

Proficient in Microsoft Office- Word, PowerPoint and Excel. Good

written and oral communication skills.

HONORS

> Won the "Best Student of the Year Award" at Dr.D.Y.Patil College of

Pharmacy, Pune, India For Year 2004-2005.

> Received the "Best Vice President Award" for organizing "Antarang 2004-

2005", an annual cultural event organized by Dr.D.Y.Patil College of

Pharmacy, Pune, India

REFERENCE

References and other details are available upon request.

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