Quality Control Development

UMA RAUL

** ****** ******, ****-***, Burlington, MA 01803

Tel: 781-***-**** Email: *******@*****.***

Profile

Analytical Chemist with Masters degree in Biochemistry, Bachelors degree

in Chemistry and fifteen plus years of experience in quality control,

research and development roles in leading international pharmaceutical

companies in Canada and India. Functions well in fast-paced, high-pressure

environment as a team member/team leader

Technical Qualifications

. Extensive experience in chemical& physical analysis of Drug substances,

Drug products conforming to Pharmacopoeia (USP/NF, IP, BP, EP) & other

non-official specification

. Extensive experience in Method validation, method development & method

transfers

. Hands on experience with the following instruments: HPLC /UPLC/Ion

exchange Chromatography. Gas Chromatograph, Spectrophotometers (UV/VIS,

FTIR, Atomic Absorption),dissolution apparatus, pH meter,KF Titrator,

potentiometer, viscometer, colorimeter, polarimeter, friability tester,

hardness tester, DT apparatus, refractometer and other allied instruments

. Hand on experience with TLC, column chromatography & other wet chemical

test

. Knowledge of FDA/ ICH guidelines, GMP regulations & various regulatory

requirements

. Preparation of SOPs,TM & WI, updating records in computerized systems

Computers: Word, Excel, Powerpoint, Validation of spreadsheets and various

laboratory software (Chemstation, Galaxie, Cerity, Empower, Labware LIMS)

PROFESSIONAL EXPERIENCE

APOTEX INC (Toronto, Canada)

March 2010- June 2013

Senior Chemist, Analytical Development

Senior Chemist, Analytical Development June

1999- April 2009

Senior Chemist, Product Evaluation

Chemist, Product Evaluation Lab

(Promoted through progressively more senior roles in the R&D Lab)

. Performed method development & validation, method transfers,

compatibility study of components, comparison of testing procedures

. Wrote method validation protocols, method validation reports, method

comparison reports, certificate of validation.

. Performed investigations and CAPA in collaboration with Quality control

department

. Reviewed old validations, Validation protocol, Method development

summary, reports

. Performed chemical& physical analysis of finished products for stability

study (such as dissolution, assay, related compounds, impurities etc.)

. Analyzed samples using GC, HPLC, UPLC, Ion exchange chromatography,

Dissolution Apparatus (manual & automated), UV/VIS spectrophotometer,

FTIR, KF titrator.

. Reviewed and evaluated analytical data & test reports submitted by other

chemists

. Tested Drug substances and Drug products for release

. Trained and assisted junior analyst

. Assisted supervisor for scheduling testing & verifying completed

schedule

. Prepared SOPs, TMs, WI, Analytical reports, OOS/OOT Investigation &

Deviation reports

. Performed User Acceptance test for Labware LIMS

. Created and published stability summary reports on Intranet

Highlights of Achievements:

. Trainer & "Super User" for Cerity and Empower software

. Certified Trainer responsible for training new chemists

. Quality tester for Labware LIMS implementation

. "Go to" person for equipment troubleshooting

SGS LIFE SCIENCE SERVICES (Contract pharma Lab in Mississauga, Canada and

division of SGS Group)

Research & Development Chemist August 2009 - To March

2010

(3 month contract April-June, 2009)

. Developed & validated testing procedures for various pharmaceutical &

Biopharmaceuticals

. Verified USP methods, transferred methods for various generic &

innovative companies

. Prepared validation protocols & final reports to client's satisfaction

under tight timelines

ALPHA LABORATORIES 1998-

1999

(Alpha Laboratories is a contract lab located in Toronto, Canada)

Analyst, Industrial Division

. Performed chemical analysis of Drug substances, Drug products, bulk drugs

according to USP/NF, BP, EU or customer methods.

. Calibrated equipments.

. Prepared of SOPs/WIs.

WYETH LEDERLE LTD, (Mumbai, India) 1990- 1998

Quality Control Chemist

. Performed chemical & physical analysis of Drug substances, Intermediates

and Drug products (tablets, liquids, ointments, Gels, nasal drops,

capsules, dry powders, suspensions, cream) conforming to Pharmacopoeia

(IP, BP, and USP) or other non-official specification.

. Operated & calibrated laboratory instruments such as HPLC, GC, UV-VIS as

well as FTIR spectrophotometer, polarimeter, KF titrator, Dissolution

apparatus & other allied instruments

. Developed & validated methods for analysis of various formulations

EDUCATION AND PROFESSIONAL DEVELOPMENT

MSc. (Biochemistry), University of Bombay (Mumbai), 1990

BSc. (Chemistry), University of Bombay (Mumbai) 1988

Pharmaceutical Chemistry - 4 mo. course, Seneca College Toronto, 2011

HPLC Method Development - 4 mo. course, Seneca College Toronto, 2011

Advanced course in "Empower 2" - Waters Inc., Toronto, 2008

Pharmaceutical Regulatory Affairs - 4 mo. course, Seneca College Toronto,

2008

Industrial Drug Legislation - 4 mo. course, Seneca College Toronto, 2007

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