Quality Control Assurance

ANURUPA SATAPATHY

E-MAIL: *********@*****.*** PHONE: 408-***-****(M)

510-***-****(H)

OBJECTIVE

To gain knowledge in Quality Assurance or Quality Control Functions & Operations and to strive

for continuous improvement for your esteemed organization.

WORK EXPERIENCE

1. WORKED AS QC OFFICER IN IPCA LABORATORY LTD FOR 1 YEARS TILL JUNE 2011

(U.S.F.D.A APPROVED)

PERFORMED THE VARIOUS QUALITY CONTROL TESTS FOR ACTIVE INGREDIENTS AND FINISHED PRODUCTS IN

ACCORDANCE WITH GMP.

PREFORMED EQUIPMENT AND PROCESS VALIDATION FOR QUALITY CONTROL TESTS.

FINISHED PRODUCT ANALYSIS (TABLETS, CAPSULES) BY UV, IR, HPLC. ASSAY, CONTENT

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UNIFORMITY, IDENTIFICATION, PHYSICAL PROPERTIES.

DISSOLUTION OF TABLETS AND CAPSULES BY UV & HPLC AND DISSOLUTION PROFILE STUDY.

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QC TESTING OF INTERMEDIATE PRODUCT (GRANNULES) BY UV, HPLC.

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WATER ANALYSIS BY TOC AND MOISTURE ANALYSIS BY KARL FISCHER TITRATOR.

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CALIBRATION OF DISSOLUTION APPARATUS. (ELECTROLAB / LAB INDIA) AND CALIBRATION OF

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U.V./VISIBLE SPECTROPHOTOMETER: SHIMADZU UV-1700.

INDEPENDENT TESTING, RELEASE & REJECTION OF PRODUCT AS PER S.O.P.

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MAINTAIN ALL LOG BOOKS OF SOPHISTICATED INSTRUMENTS & OTHERS.

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DAILY CALIBRATION OF BALANCE & PH METER.

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MAINTAIN ALL DAILY DOCUMENTATION & LABORATORY KEEPING AS PER GLP.

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PREPARE CERTIFICATE OF ANALYSIS(COA), ASSISTED IN INVESTIGATIONS OF OOS RESULTS; PARTICIPATED

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IN SELF-INSPECTIONS

Knowledge about SDS-PAGE, Western Blot, ELISA.

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2. GILBERT PHARMACEUTICALS: MANUFACTURING AND QUALITY CONTROL [2006-2007]

CONDUCTED CHEMICAL ANALYSIS ON RAW MATERIALS, IN-PROCESS MATERIALS AND FINISHED PRODUCTS

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USING SPECIALIZED INSTRUMENTS AND APPARATUS SUCH AS HIGH PERFORMANCE LIQUID

CHROMATOGRAPH (HPLC), ULTRA-VIOLET SPECTROPHOTOMETER, FOURIER-TRANSFORM

SPECTROPHOTOMETER (FT-IR) AND DISSOLUTION APPARATUS, TLC.

CALIBRATED PH METER, ANALYTICAL BALANCES, DISSOLUTION APPARATUS, UV SPECTROPHOTOMETER,

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HPLC.

● MAINTAINED THE DOCUMENTATION OF THE QC TESTS, TEST PROCEDURES, EQUIPMENT VALIDATION.

QC. LABORATORY INSTRUMENT HANDLING

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HPLC ( WATERS ALLIANCE, SOFTWARE HANDLED : EMPOWER)

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U.V./VISIBLE SPECTROPHOTOMETER (SHIMADZU UV-1700, PERKIN ELMER)

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KARL FISCHER TITRATOR (METTLER TOLEDO)

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FTIR SPECTROSCOPY (SHIMADZU SOFTWARE HANDLED : IR SOLUTION )

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DISSOLUTION TESTER (ELECTROLAB)

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GAS CHROMATOGRAPHY (PERKIN ELMER)

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DISINTEGRATION TESTER (ELECTROLAB) AND FRIABILITY APPARATUS (ELECTROLAB)

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PH METER,POLARIMETER,AUTO TITRATOR, TOC (SHIMADZU),TLC

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EDUCATION

Certificate: Certificate in Drug Regulatory Affairs (DRA) at University of California Santa

Cruz 2012.

Relevant courses

Drug Development Process

Good Manufacturing Practices

Good Clinical Practices

Interacting with the FDA

Regulation of Medical Devices and Diagnostics.

Regulation of Drugs and Biologics

Regulatory Submissions: Drugs and Biologics

RA Professional's Toolbox

Preparing for FDA Inspections and Conducting Sponsor Audits

Document Preparation: Protocols, Reports, Summaries

Value added to quality audit

Projects and Seminars:

IND Submission:

Prepared an IND submission for approval of a new fictitious drug. (Maraviroc)

This submission was prepared in accordance with 21 CFR, ICH and FDA guidelines.

This involved suggesting CMC changes, manufacturing and formulation changes, designing non-

clinical and clinical trials and related regulatory issues.

Analysis and tabulation of FDA Warning Letter.

Prepared a meeting request to FDA (Type B).

Prepared Informed Consent, Clinical study report, protocol and summary.

Seminar presented on the approval of Biologics, product jurisdiction and approval of

combination products (Medical devices).

Master in Pharmaceutical Science Biju Patnaik University of Technology. India

GPA: 8.4/10

Courses Taken

Biostatistics

Modern Analytical Techniques

Drug Regulatory Affairs & Intellectual Property Rights

Stability of Drugs & Drug Products

Phyto – Pharmaceutical Analysis

Quality Assurance of Pharmaceuticals

Advance Pharmaceutical Analysis

Projects:

Method development and Validation of Analytical Methods for Determination of

Piracetam, Doxicycline, Tinidazole in Pharmaceutical Dosage Forms by UV and HPLC.

Method development for new drugs if any suitable methods are not available by developing a

stability indicating method for drug product/drug substance is stable in stress conditions or not

whether there is any interference of excipients with the drugs by doing accuracy study.

Purity of a drug by doing HPLC method

COMPUTER SKILL

OPERATING SYSTEMS: WINDOWS XP/VISTA

OTHER TOOLS: MS OFFICE 2007

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