Pvt Ltd Manufacturing

HIREN PATEL

** ****** ***, ****** ** *****

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

Phone: 732-***-****

Objective: To obtain full time position in the area of production in

Pharmaceutical and cosmetic Industry.

Education: Stevens Institute of Technology, Hoboken, New Jersey

05/2010

Master of Science in Pharmaceutical Manufacturing Engineering

B. M. Shah College of Pharmacy, Modasa, Gujarat, India

06/2006

Bachelor of Pharmacy

Skills: Lab Skills: Operation of dissolution apparatus,

disintegration apparatus, HPLC,

Spectrophotometer, infrared spectrophotometer, differential

scanning

Calorimeter, pH meter, polarimeter, conductometer, Karl Fischer

apparatus, TOC

analyzer.

Software: Microsoft Office 2007-MS Word, PowerPoint, Excel,

Microsoft Project, Microsoft Visio

Professional Work Experience:

Bio-Pharm Pvt Ltd, Levittown, PA 10/2013 to

Present

Production supervisor

. Production planning, manufacturing operations, and

statistical analysis of variance reports

. Prepare and implement procedures, process validation

protocol, cleaning validation protocol

. Prepare and maintained Installation Qualification,

operational qualification and process qualification document

for equipment

. Prepare investigation report during batch failure

. Provide quality improvement and standardization

. Review and update Batch Production record and sops every

month

. Perform audit and vendor qualification

. Responsible for production scheduling, cycle time management,

capacity utilization

. Update for incoming raw material status with QC department

. Maintain calibration schedule for Load cell, vessels,

mixture, temperature data logger, and Purified water system

as per sops.

. Provide GMP training and sop training monthly basis to

operator.

. Implement Chemical Management system dispensing, warehouse,

manufacturing and packaging department.

. Follow through ensuring leads, operators and other personnel

are accountable for their areas of responsibility and to

ensure smooth work transition between the two shifts.

. Responsible for new product development, process

development, scale up studies and process validation

. Coordinate development activity and provide troubleshooting

Bio-Pharm Pvt Ltd, Levittown, PA

01/2012 to 09/13

Production supervisor

. Responsible for Production Planning and Manufacturing

operation

. Provided GMP training to operator

. Prepared and implemented process validation protocols

. Prepared and maintained Installation Qualification,

operational qualification and process qualification document

for equipment

. Implemented Chemical Management System

. Maintained temperature and humidity graph throughout

facility.

. Maintained inventory for raw material and non printed

component.

. Updated for incoming raw material status with QC department

. Maintained calibration schedule for Load cell, vessels,

mixture, temperature data logger, and Purified water system

as per sops.

. Reviewed Master packaging record and batch manufacturing

record

. Released non printed and printed material as per

specification

. Calculated % reconciliation, % yield and % waste of product

and other component.

. Assisted in preparation of Validation Master Plan

. Involved in CAPA and Risk Assessment

. Coordinated with other department

Stevens Institute of Technology, Hoboken, NJ 08/2009

to 05/2010

Teaching Assistant

. Assisted Professors in on-campus courses that include

grading, arrangement of lectures and update of course

material.

. Assisted in PME tutorial program.

. Mentored students

Aquila LABS Pvt Ltd. Gujarat, India

05/2006 to 08/2007

Quality Associates

. Provided GMP, validation protocol sampling and sop training

to QA inspector

. Prepared and implemented process validation protocols

. Prepared and maintained Installation Qualification,

operational qualification and process qualification document

for equipment

. Implemented Chemical Management System to packaging

department

. Maintained temperature and humidity graph throughout

facility.

. Involved line clearance, in-process check and cleaning

verification of packaging line, equipment, manufacturing area

and dispensing area.

. Performed inspection check during API addition to

manufacturing operation.

. Prepared specification for Printed Packaging component and

non-printed packaging component.

. Monitored cleaning, equipment usage, Purified water system,

Weighing calibration and temperature logbook weekly.

. Reviewed Master packaging record and batch manufacturing

record

. Released non printed and printed material as per

specification

. Calculated % reconciliation, % yield and % waste of product

and other component into master packaging record.

. Assisted in preparation of Validation Master Plan

. Involved in CAPA and Risk Assessment

. Maintained inventory for printed component.

. Prepared Certificate of analysis for finish good products.

. Monitored GMP practice in Dispensing, manufacturing and

Packaging area.

. Reported error, deficiencies, discrepancies and observation

to management

. Coordinated with other department.

Aurovilla Pvt Ltd., Gujarat, India

05/2005 to 07/2005

Manufacturing Technician

. Received training in Planning, Production, Packaging and

Storage of oral dosages

. Testing of Pharmaceutical raw materials and oral formulations

. Handled machinery, equipments and instruments for production

and analytical testing of oral

. Organized record keeping and personnel management

Project Work: In class Project:

. Prepared and executed Design Qualification /Installation

Qualification/ Operational Qualification / Performance

Qualification and cleaning validation protocols.

. Performed DOE (Design of Experiments), Gage R & R studies.

. Have detailed knowledge regarding change control, Failure

Mode and Effect analysis (FMEA), and Root cause analysis.

. Studied Computer Validation in detail and prepared paper on

Validation of Spreadsheet which included need and extent to

which spreadsheet need to be validated in comparison to LIMS

. Prepared thesis on Protein and Peptide Drug Delivery System

from available research paper

Research Work:

Working on cleaning validation by performing clean ability study

using TOC

Analyzer and visual coupons (Analytical Method Development)

References: Available on request.

Contact this candidate