Project Management

URVI PATEL

Authorized to work in US

*** ****** ****** • Jersey City, NJ 07307  ****.*******@*****.***  201-***-****

OBJECTIVE: To attain a position in the Field of Pharmaceutical/ Biopharmaceutical industry

EDUCATION: Stevens Institute of Technology, Hoboken, NJ

Master of Science in Pharmaceutical Manufacturing Engineering, MAY-2010

GPA -3.54

Course Work: Validation and Regulatory Affairs in Pharmaceutical Manufacturing, Contemporary

Concept of Pharma-Validation, Design/Management of Sterile Pharma Manufacturing,

Project Management, Pharmaceutical Finishing and Packaging, Design/Management of Sterile Pharma Manufacturing, Good Manufacturing Practice in Pharmacy, Introduction to Project Management, Bioprocess Technology in Pharmaceutical Manufacturing

Rajiv Gandhi University of Health Sciences, Karnataka , India

Bachelor of Pharmacy, DEC-2007

GPA-3.53

Course work: pharmaceutics, Pharmacology, pharmacokinetics, analysis, chemistry.

SKILLS: • Knowledge about cGMP and GLP

• Software: Minitab 15 (Gage R&R, Six Pack Capability, DOE, Histograms)

Microsoft Office 2007, Microsoft Project 2007

• IQ, OQ, PQ Protocol Documentation, FMEA, PFD, VMP, SOP

• Regulations: FDA, DEA, EPA, OSHA, ISPE guidelines, ICH guidelines

• Good knowledge of the chemical composition, structure and properties of substance and of the chemical

Process and transformation

• Knowledge of bioprocess technology, aseptic filling line and clean room environment

LAB SKILLS: • Titration, Chromatography Techniques- HPLC

• Granulation, Disintegration, Dissolution of tablets

• Knowledge of Swab sampling, Cleaning Validation, TOC analysis techniques.

RESEARCH: Stevens Pharmacy Research Center, Hoboken, NJ Jan-2010 – Present

Research Assistant

• Performing cleaning ability study on batch scale for cosmetic Products

• Making batch scale CIP system and solving problems

• Working on recovery of naphthalene during TOC study

• Protocol developed for TOC Analysis

• Assisting with process development, optimization, scale-up and validation studies

• Responsible for the analysis of samples, using a wide range of analytical techniques to

cGMP and other appropriate methods to produce high quality data

EXPERIENCE: ZYDUS CADILA Pharmaceutical Ltd, Gujarat, India Jan 2008- Jun 2008 QC Analyst

• Performed in process quality control tests for tablet including dissolution tests

• Prepared test solutions, compounds, and reagents for laboratory personnel to conduct test

• Documentation, responsible to maintain SOPs revision updated, Improve SOPs and

Production Batch Records to be easier to follow to comply with cGMP.

PROJECT: HBD Projects (Cookies production same as a Tablet production) FALL 2009

Project Engineer

• Responsibility to write, review, approves and executes Installation, Operation,

Performance Qualification and / or Process Validation protocols

• Reviewed User Requirement Specifications (URS), Functional Specifications (FS), Installation

Qualification (IQ), Operational Qualification (OQ), Traceability Matrix (TM), Validation Summary

Report for Automated Tablet Press

• Documentation Management: Warning letter trends, electronic solutions, related regulatory aspects

PAPERS: • Layout of bottle and blister Packaging line

• Modern instrumentation and Control systems for bioreactors

• Facility for making soft gelatin capsule (sterile products)

REFERENCE: Available on request

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