RESUME

Ankita Shah

acdl6y@r.postjobfree.com

M. S. In Pharmaceutical Manufacturing

OBJECTIVE:

To secure challenging position in pharmaceutical Industry that will allow

me to utilize my knowledge and expertise for developing and implementing

improvements to quality system further contributing towards the perspective

growth of the company.

PROFESSIONAL SUMMARY

. Having two plus years of experience in FDA regulated Pharmaceutical

and Biological industry

. Perform cleaning validation of tanks and parts washer using swab and

rinse sampling method

. Basic Understanding of analytical instruments like HPLC, Dissolution,

Karl Fischer, UV Spectrometer and TOC analyzer

. Having knowledge of New Drug Development and Review Process.

. Participate in root cause analysis, change control and Implement CAPA

. Knowledge of 21 CFR part 210, 211 and ICH guidelines

. Review batch record for any documentation error

. Knowledge of CGMP and CGLP requirements

. Experience in using statistical software like MINITAB for validation

and design of experiments(DOE) related to pharmaceutical industries

. Aseptic Gowning qualification

. Knowledge of Clean in Place(CIP) and Steam in place(SIP)

WORK EXPERIENCE (Total Years of Experience; 2 years and 9 months):

Hyde Engineering+Consulting, Bedford, Ohio

Designation: Validation Engineer

Working Period: April 2013 to June 2013

Responsibilities:

. Executed cleaning verification studies, IOPQ and cleaning validation

. Generated and executed the protocol for the spray ball coverage on

tanks

. Collected rinse and swab sampling to test TOC, Conductivity, Bio

burden and Endotoxin testing

. Handled Discrepancies by identifying the root cause, assessing risk,

investigating it and accordingly taking corrective actions to prevent

errors

. Summarized results for cleaning validation

Gemini Pharmaceutical, Commack, New York

Designation: QA Specialist

Working Period: September 2011 to March 2013

Responsibilities:

. Performed line clearance of Packaging lines, compression rooms,

blending and coating area

. Verified labels and shipper label coming from label control department

with packaging instruction paperwork. Also responsible for issuing

packaging components after verifying their lot numbers in batch record

. Performed and document one hour in process check in packaging and

compression batch record as per QA protocol and SOP requirements

. Responsible for identifying deviation that occurs during operations

and take appropriate actions

. Handled root cause analysis when some defects are noted and complains

are coming from customers and implement them using problem solving

techniques like CAPA

. Reviewed batch record and associated paper work for any documentation

error made during packaging and production operations

. Performed AQL sampling of coated products, packaging components and

labels

. Calibrate weighting scale and caliper and document in respective log

books

. Monitored preventive and Maintenance records for all equipment

. Temperature and Humidity monitoring of Packaging and Production area

. Performed metal detector test before starting new batch and whenever

is needed, do automatic setup of the machine

Sanofi Pasteur, Swift water, Pennsylvania

Designation: Manufacturing Technician

Working Period: March 2011 to August 2011

Responsibilities:

. Worked as a Manufacturing Technician in Grade A and B area with proper

gowning requirements

. Have an experience for work in C-GMP environment

. Performed CIP after end of the batch and SIP at beginning of the batch by

following SWI

. Performed routine environmental monitoring to assess the viable and non-

viable particulate levels within classified manufacturing rooms(Including

Class 100) and Supportive rooms(Class 10,000 and Class 100,000)

. Performed autoclave unload of the filler parts in the Grade A area

. Documented each sterilized parts used during filling in the Batch filling

record

. Was responsible for various manufacturing support activities like

assembling and dissembling of the various filler parts before and after

their use, Filter testing of Inova and SIP filter, Glove integrity

testing, cleaning of RABS, line clearance of the filling room

. Have an idea of how to fill log books for different processes and BFR of

the each product

. Operation of equipment in the filler through use of HMI troubleshooting

using routine and non-routine interventions

. Performed product and stopper re-conciliation after end of each sub or

master lot.

Stevens Institute of Technology, Hoboken, New Jersey

Designation: Lab Supervisor (Project work)

Working Period: July 2010 to December 2010

Responsibilities:

. Performed various experiments like DOE of blend uniformity of pre

blend and cleaning process, Conductivity of the components using

conduct meter

. Prepared Standard operating procedure for the cleaning process for all

equipments which include blade and bowl of mixer

. Performed experiment of the Total Organic Carbon Analysis for the

mixer bowl using Sevier's 900 Portable TOC Analyzer

. Reviewed installation qualification, Operational qualification and

performance qualification of the various equipments like mixer and

oven

. Reviewed Batch Record and Process validation protocol for the HBD

process

Relax pharmaceuticals, Vadodara, Gujarat

Designation: Intern

Working period: May 2008 to June 2008

Responsibilities:

. Examined, participated and supervised manufacturing and packaging of

tablets

. Through understanding of implementing GMP aspects in manufacturing

process

. Responsible for reviewing all required paperwork and reports of the

Quality Assurance function like QA audit reports, calibration reports,

validation final reports

. Ensured correct sample plans were used, ensuring any materials

utilized were released and correctly accounted for, accuracy and

completeness of documentation, and equipment used met designated

specifications.

Ambalal Sarabhai Enterprises Limited, Vadodara, Gujarat

Designation: Intern

Working period: May 2007 to June 2007

Responsibilities:

. Assisted in the Production Department, Quality Control and Quality

Assurance area

. Performed the assay of the various tablets by Spectrophotometer

. Performed in Process Quality Controls Tests for the tablets such as

Dissolution test, Disintegration test and Friability test

EDUCATION:

. January 2009 to December 2010: master of Science in Pharmaceutical

Manufacturing from Stevens Institute of Technology, NJ, USA with

GPA 3.599

o Certificate in Validation and regulatory Affairs

. September 2004 to May 2008: Bachelors of Pharmacy from A. R.

College of Pharmacy with Aggregate 62.3%

RELEVANT COURSE WORK:

Pharma ceutics, Analytical Chemistry, Dosage from Design and Bio

Pharmaceutics, Pharmaceutical Microbiology, Introduction to Pharma

Manufacturing, Validation and regulatory Affairs in Pharma, Pharma

finishing and packaging, Bioprocess tech in API manufacturing, Regulation

and compliance in Pharma, Contemporary Pharmaceutical validation.

TECHNICAL SKILLS:

Lab skills Cleaning validation using swab sampling method, LAL

testing, Aseptic Gowning Qualification, Filter testing,

Glove integrity testing, Operation of HMI and PLC in the

filler, CIP and SIP of the filling line, Autoclave unload

in class A area, Core to clean, Line clearance of the

room, Titration, Spectroscopy, HPLC, Viscosity Testing,

TOC Analysis, Disintegration, Dissolution and granulation

techniques, Tablet manufacturing and coating

Computer Microsoft Word, Excel, Power Point

skills

Software Minitab 15 (Gage R&R, Six pack capability, Design of

Experiment, Histograms), M-file

Trouble Perform linearity and gage R&R study, Monte Carlo

shooting Stimulation chart, Control chart study, X bar and R bar

Skills chart study, Knowledge of Design of experiment and

process capability

ACADAMEIC PROJECTS: Computer System Validation Master Plan, FDA Consent

Decree and case studies, Innovative approach in Tablet Manufacturing, PAT

approach in Building Automation System

Personal details:

Date of Birth : 22nd September, 1986

Marital Status : Engaged

Nationality : INDIAN

Languages known : Gujarati, Hindi, English

RESIDEANTIAL ADDRESS:

B/94, Shantinagar Society,

Behind Sahyog Society,

Refinery Road, Gorwa,

Vadodara, 390016, Gujarat

Phone no. - +91-886*******

Contact this candidate