ANKUR PATEL

Cell: 201-***-****

E-mail: ably2l@r.postjobfree.com

Objective To associate myself with an organization that provides me an opportunity to show my skills and

ability, and to be a part of the team that works dynamically towards the growth of the

organization.

• •

IQ/OQ/PQ preparation/execution Batch Record review

• •

Statistical data review Deviation and Investigation

• •

Annual Product Review Change Control Administration

• •

FMEA QC tests

• •

CAPA Raw Material Sampling

• •

Validation report preparation Equipment Calibration

• •

21 CFR Part 210 & 211, Part 11 SOPs preparation

• Cause and Effect diagram

Skills

Laboratory HPLC Waters (Empower 2)

Instrument TOC analyzer (Sievers 900 Portable)

GC-Perkin Elmer Clarus 500

UV spectroscopy, FT-IR

X-Ray Diffraction

Karl-Fisher

TLC

Work Amneal Pharmaceuticals, Hauppauge, NY June 2011-Current

Experience Scientist 1

Qualita

•

tive and Quantitative testing of API, Finished (FP) & Stability products (ST) by using HPLC,

GC, UV-VIS Instruments.

Perfor

•

med various analytical tests such as Dissolution (Apparatus I and II), Content Uniformity, Assay,

Related Substance (Impurities), Moisture Content, Weight Variation, Wet Chemistry

Mainta

•

ined Stability sample records in LIMS

Metho

•

d Validation and reviewed technical reports from validation

Perfor

•

med stability testing to determine product shelf life and quality performance over the time by

following SOPs, USP

Execut

•

ed Risk assessment & CAPA activities in case of any deviations, failures.

Calibra

•

tion of Lab equipment

Pooled

•

out Stability sample every day from Stability Room and Stability Chambers

Prepar

•

ed and Maintained SOPs for Lab Equipment

Mainta

•

ined Equipment Logbook

Excelle

•

nt knowledge for troubleshooting of HPLC, GC, UV-VIS, Karl Fisher, TLC, FTIR

Stevens Institute of Technology, Hoboken, NJ December 2009-May 2010

Project Engineer

• Prepared and reviewed SOPs for equipments and process

• Calibrated laboratory equipment

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

• Reviewed and assisted responsible person to prepare Validation master plan and Cleaning

validation Protocols

• Prepared and Executed IQ/OQ/PQ protocols

• Performed FMEA for equipment and process

• Prepared various manufacturing records and protocols as per cGMP

• Perform investigations and prepare associated reports for deviations related to QA, Report

quality issues to Quality Management

• Performed CAPA investigation and followed up with responsible person

• Enforced cGMP and SOPs on floor to ensure that the Quality procedures are followed

• Detailed knowledge of cGMP Guideline and FDA regulation

Mediwin Pharmaceutical, Gujarat, India June 2007-August 2008

Regulatory Affair

• Annual Batch and Batch Record

Review

• Review and Evaluate regulatory

documents

• Prepared documents for ANDA filling

• Communicated and coordinated with

responsible team to complete filing in time

• Following the Standard Operating

Procedure for document handling and maintenance

• Maintain compliance with regulatory

requirements for generic drugs for the US market.

• Knowledge of all FDA requirements

relating to submission of regulatory documents

Education Stevens Institute of Technology, Hoboken, New Jersey, USA

Master of Science in Pharmaceutical Manufacturing May 2010

GPA: 3.73

S. K. Patel College of Pharmaceutical Education and Research, Gujarat, India

Bachelor of Science in Pharmacy July 2008

GPA: 3.80

Certificates Bioprocess System in Pharm. Manufacturing, Project Engineering in Pharm. Manufacturing

Activities International Society of Pharmaceutical Engineering (ISPE)

Pharmacy Council of India (PCI)

References Available upon request

Contact this candidate