CV_-_SMRITI_SHARMA_10.2

Smriti Sharma M.Sc. Biotechnology

Mob. +91-9982284260

Home +91-9999021225

Email: [email protected]

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Personal information:

Address :

Smriti Sharma

W/o Sumit Sharma, G-904,

Sethi Max Royal,

Sector-76, Noida.

(UP) 201304

D.O.B.: Oct-24, 1987

Father’s Name: -

Mr. B.L. Sharma

Marital status: Married

Hobby(ies):

Traveling, Dancing and

Listening Music

Language known

English, Hindi

CAREER OBJECTIVE

To put my learning into practice, yield the best of my potential, become an asset for the

organization and develop in professional and personal life by fulfilling the

organizational goals.

BRIEF SUMMARY

Having 3 years 7 months’ experience as a “Research Associate”, Junior Chemist”

& “Process Associate”

Analysis of API & all type formulation with system suitability test

Testing of pharmaceutical product, API etc.

Chemical testing , Method Validation & Technology Transfer

Perform the data entry of the Case Report Forms (CRF) into the software like

Pheedlt, Clinion

PROFESSIONAL AND ACADEMIC QUALIFICATION

Pharmacovigilance Training in Oracle Argus Safety with Project from Biomed

Informatics Institute.

Post Graduate Diploma in Advance Clinical Research & Pharmacovigilance from

ICRI-Delhi

M.Sc. Biotechnology in 2009-2011 from Jaipur National University, Jaipur

B.Sc. Biotechnology in 2007-2009 from Rajasthan University, Jaipur, Rajasthan

Senior Secondary with Chemistry, Physics & Biology in 2005 from Central

Board of Secondary Education

TECHNICAL SKILLS:

Instrument Handling and Calibration

High performance liquid chromatography (Shimadzu & Waters)

U.V. Spectrophotometer

Dissolution Apparatus (Manual & Autosampler)

KF Titrator

Disintegration Test Apparatus

pH Meter

Software Knowledge of Lab Solution & Empower 3

Chemical testing , Method Validation & Technology Transfer


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Professional Experience

Organization CLINICAL DEVELOPMENT SERVICE AGENCY (CDSA) [An extramural unit of

THSTI, Dep. Of Biotechnology, Ministry of Science & Technology, Gov. of India]

(Aug 2016-Present)

(Aug 2016 To Present)

Designation CLINICAL DATABASE MANAGER ( Consultant)

Work

Experience

Manage all stages of data management quality management activities from study startup to

database close.

Program procedures to validate the data in the database and perform testing of the same with test

patient data (UAT)

Develop edit check to support implementation of trial.

Test and execute validation procedures.

To complete database close / lock / freeze checklists.

To perform reconciliation of the clinical database against safety data, laboratory data and other

third party data as appropriate

Review CRF / eCRF data entry conventions

Responsible for tracking of receipt of CRFs. All CRFs received by courier or other means are

tracked and logged manually and perform data entry

Interact with other project team members to support the set-up, maintenance, and closure of the

Data Management aspects of the project

Performing day –to – day quality control and data processing according to the principals of Good

Clinical Practices (GCP)

Resolving DCFs related to safety and efficacy panels enable data cleaning leading to qualitative

database

Effective generation, resolution and updation of DCFs

Quality Check of Database Design, Validation Program, Annotated CRF, Data Extract Views,

Laboratory Details, Site and Investigators and Final Data Listings

Co- Monitoring with Research Officer and Study Monitor for the Verapamil Study , GLSE Study

Maintaining clinical study documents

Coordinate the archiving of study databases and related documents

Any other tasks assigned by line manager


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Organization JSS MEDICAL RESEARCH INDIA LTD (Formerly known as Max Neeman

International) (Jul 2015 To Apr 2016)

Designation PROCESS ASSOCIATE

Work

Experience

Performed the Data Entry of the Case Report Forms (CRF) into the software like Pheedlt, Clinion.

Entered and processed the laboratory data of the CRF in the database.

Performed Database Screen Testing of CRF.

Raised the Data Entry alert forms (DEAFs) for CRF.

Updated records and information of the CRF in the database.

Prepared data for inputting into databases.

Organization AMOL PHARMACEUTICAL PVT. LTD. JAIPUR :- An (ISO17025, NABL

CERTIFIED) (Apr 2013 To Nov 2014)

Designation JUNIOR CHEMIST

Work

Experience

Review of the Standard Operating Procedures, specifications, Standard Test Procedures &

worksheets of Raw Materials , Finished Products and co-ordination with QA to fulfill the regulatory

requirements

Review of protocol report and supporting documents

Successful coordination of audit, inspections and visit by clients of the Company or drug authorities

Handling and Calibration of HPLC, U.V. Spectroscopy, Disintegration Test Apparatus, Dissolution

Test Apparatus

Analysis of API & all type formulations of pharmaceutical & finish product with system suitability

test

Chemical analysis of drugs, API & operation of general instrument

Testing of Raw materials, tablets, capsules, suspensions, syrups, ointments products etc.

Prepare mobile phase & dilutions of drugs for HPLC analysis

Prepare dilutions of drugs for U.V. analysis


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Organization MACLEODS PHARMACEUTICAL LTD. MUMBAI

(FROM NOV 2011 TO FEB 2013)

Designation RESEARCH ASSOCIATE

Work

Experience

Preparation of Specification and Standard Test Procedure for various dosage forms like Tablets,

Capsules, Oral liquids, Injections, Ointments, Inhalers and Nazal Spray.

Updatation of Specification and Standard Test Procedure of finished dosage form as per updated

Pharmacopeia’s & transfer of analytical based documents to various manufacturing location.

Preparation of responses of query’s received from different Regulatory Agencies.

Review of documents like stability data, method of analysis of supplier’s vs in-house.

INTERNSHIPS AND TRAINING

Organization CENTRAL INSTITUTE OF MEDICINAL AND AROMATIC PLANTS (CIMAP) ,

LUCKNOW Period JAN 2011 TO JUNE 2011.

Assignment

Study of Anti-aging activities of aromatic phytomolecules using C.elegans as a model system.

Determine anti-aging effect on C.elegans using citrus and limonene as a phytomolecules.

Carried out various physiological and chemical parameters to determine antiaging effects

Industrial

Training

PACRA recognition certificate for research on “MALAYSIA” for clinical trials (10 April 2015)

Clongen Biotechnology Pvt Ltd., Noida (From July 2008- Aug 2008)

Boro Caps Pharmaceutical, Jaipur, Rajasthan (From 1 Aug, 2008 to 31 Aug, 2008)

Date:

Place: Noida (Smriti Sharma)

Documents

CV_-_SMRITI_SHARMA_10.2