View
11
Download
0
Category
Preview:
Citation preview
Smriti Sharma M.Sc. Biotechnology
Mob. +91-9982284260
Home +91-9999021225
Email: sharmasmriti2009@gmail.com
Page | 1
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
Smriti Sharma M.Sc. Biotechnology
Mob. +91-9982284260
Home +91-9999021225
Email: sharmasmriti2009@gmail.com
Page | 2
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
Smriti Sharma M.Sc. Biotechnology
Mob. +91-9982284260
Home +91-9999021225
Email: sharmasmriti2009@gmail.com
Page | 3
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
Smriti Sharma M.Sc. Biotechnology
Mob. +91-9982284260
Home +91-9999021225
Email: sharmasmriti2009@gmail.com
Page | 4
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)
Recommended