Quality Control Assurance

M EGHA PATEL

*** **.***** *** • Jersey City • NJ • 07306

***********@*****.*** • 848-***-****

Objective:

Well organized result oriented pharmacy under graduate and graduate looking for an opportunity in a

pharmaceutical company

Education:

2009 – 2010 S TEVENS INSTITUTE OF TECHNOLOGY HOBOKEN, NJ

M.S. Pharmaceutical Manufacturing Engineering

GPA 3.6

2004 - 2008 S ARDAR PATEL UNIVERSITY GUJARAT, INDIA

Bachelor in Pharmacy

GPA 3.7

With emphasis on the following topics : Introduction to Pharmaceutical Manufacturing, Good

Manufacturing Practice in Pharmaceutical Facility Design, Validation & Regulatory Affairs in

Pharmaceutical Industry, Contemporary Concept of Pharmaceutical Validation, Regulatory &

Compliance in the Pharmaceutical Industry, Pharmaceutical Finishing & Packaging System – Solid

Dosage, Quality in Pharmaceutical Manufacturing, Introduction to Project Management

Presentation:

• Qualification/validation Project

• IQ/PQ protocol for Gas Cook Top

• Newer approaches for packaging system

• Comparison of Quality System Requirement between EU and USA for medical devices.

• Manufacturing of Soft Gelatin Capsule

• ICH Q9 Quality Risk Management

Skills:

Instrumentation:

HPLC, UV-Spectroscopy, Dissolution apparatus, Disintegration apparatus, Hardness Tester, Friability

apparatus and Total Organic Carbon apparatus

Skills acquired through experience and education:

SOPs preparation, FMEA, IQ/OQ/PQ preparation/execution, Deviation and investigation, Annual

Product Review, Statistical data review, FMEA, CAPA, TOC analyzer (Sievers 900 Portable),

Change Control, Administration, Raw Material Sampling, Equipment Calibration, Cause and Effect

diagram, Batch Record review, QC tests, Knowledge about Quality tools like Six Sigma and lean

manufacturing.

Other Skills:

21 CFR part 210 & 211, part 11, Windows 98/XP/Vista, Microsoft office (Word, Excel, Visio,

Project Management), Minitab 15 (Statistical Software to Improve Quality), M-files (Electronic

Document Management System).

Experience:

Sun Pharmaceutical Industries Ltd (May 07 – Dec 07) GUJARAT, INDIA

Trainee: QC Analyst

• Performed Assay of Tablets, Content uniformity, Dissolution analysis, Disintegration

test, Hardness test, Friability test

• Excellent knowledge about HPLC, UV-spectroscopy, Dissolution apparatus,

Disintegration apparatus

• Calibrated Laboratory equipments

• Prepared and Reviewed SOPs

• Assist responsible person for FMEA of equipment and Process

• Detailed knowledge of cGMP Guideline and FDA regulation, and Aseptic Process

• Operate TOC (Sievers 900 Portable) Analyzer for the Cleaning validation

• Support and perform

CAPA investigation and follow up with responsible persons

• Report quality issues to Quality Management

• Knowledge of Packaging system

• Responsible for all levels of quality control/quality assurance

Neel-Nayan Pharmaceutical Pvt. Ltd . (May 08- Nov 08) GUJARAT, INDIA

Trainee: Production Department

• Production assistant in the tablet manufacturing area.

• Learned and executed quality control tests for finished oral solid dosage forms.

• Analyzed raw material, in process and finished product specification.

Certificates: Pharmaceutical manufacturing Practice, Validation and Regulatory affairs

References: available upon request

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