Curriculum Vitae

VIVEK M. SUTHAR

M.S. PHARMACY (Q.A & Pharmaceutical Analysis), B.PHARM

OBJECTIVE:

Seeking for a responsibility & challenging opportunity that will utilize & enhance my skill where I can actively devote my abilities through dedicated hard work.

ACADEMIC CREDENTIALS

Sr.No.

Qualification

Board/University

Year

Percentage/SPI

1

M.S.Pharmacy

Gujarat Forensic Sciences University

2014

7.1 CPI

2

B. Pharm

Gujarat Technological University

2012

7.4 CGPA

3

H.S.C.

Gujarat Secondary and Higher secondary Education Board

2008

74.00%

4

S.S.C

Gujarat Secondary Education Board

2006

82.00%

MODULES (M.S. PHARMACY)

Forensic Science and Biostatistics, Forensic Drug Chemistry and Toxicology, Modern Pharmaceutical Analysis, Nano Biotechnology, Fundamentals of Intellectual Property-Regulatory Guidelines & Technical Management, Federal Regulation of Drugs and Pharmacy, Advance Pharmaceutical Analysis, Impurity Profiles of the Drugs, Quality Assurance & Quality Management, Pharmaceutical Stability Studies, Nano Analytical Techniques, Drug Abuse, Biological Standardization and Pharmacological Screening and Natural Medicinal Products.

AREAS OF INTEREST

R&D

Quality Assurance

Analytical Development Lab

Bio-Analytical Lab

ACADEMIC PROJECTS

TITLE: Studies on active constituents of Cassia Angustifolia and their Impurity Profile.

INSTRUMENTS USED

Tecan Freedom Evo ware- Liquid Handling System

Hamilton Liquid handling System-Micro lab Star

LC-MS/MS: MDS Sciex API 4000 coupled with Shimadzu UPLC

LC-MS/MS: SHIMADZU 8045 AND 8060 coupled with Shimadzu UPLC

UV Spectrophotometer (Jasco V-630)

Spectrofluorometer (Jasco EP-6500)

FTIR (Jasco-4100)

Zetasizer (Malvern Nano-ZS)

DSC (PerkinElmer DSC-6000)

HPLC (Jasco PU-2080 plus)

Smart HPLC (GL science LC-800)

SFC (Jasco PU-2080 plus)

RESPONSIBILITY AS BIOANALYTICAL MONITOR

Online and Retrospective Bio analytical Phase of the study of the BA/BE, Phase-I and Clinical Trials.

Review of Study Raw Data, Final Cross Table, Accountability, Traceability for Accuracy and Adequacy.

Review of Bio analytical Method Development, Validation and Study Source Documents and Reports.

Review Standard Operating procedures, Standard Testing Procedures and Executed Study documents for completeness and clarity.

Ensuring GLP Compliance and Regulatory Requirements.

Communication with Bio analytical Team to ensure the appropriate CAPA.

Review of Calibration and Preventive Maintenance of all Instruments in Bio analytical laboratory.

Preparing the Monitoring Checklist, Reports and Taking follow up for the CAPA by Site to solve all the Observations and providing them to suitable suggestions/recommendation if required.

RESPONSIBILITIES AS ANALYST

Develop and Validate Bio analytical method in biological matrix.

Analyze biological samples of allotted projects.

Handling and the operations of LC-MS/MS.

Prepare and review draft SOPs and Method SOPs.

Preparing and checking of labels for Instruments, Method Validation / Development.

Ensure effective implementation of GLP and 21 CFR by checking of instruments labels, completeness of logbooks of equipment.

Reporting about the status of an on-going projects and method validation to group-leader.

To communicate about the performance of lab equipment and status of resources availability to the group-leader.

Transfer of concentration table of subject sample for pharmacokinetic analysis.

To resolve the system, projects and method validation related QC/QA findings.

Work as per OECD GLP principles.

EXTRA CURRICULAR

National Level Seminar:

1)National seminar on Green Chemistry at Cambay Grand, Ahmedabad by Institute of R&D, Gujarat Forensic Sciences University, Gandhinagar.

2)National seminar on Supramolecule and Nanotechnology at Institute of R&D, Gujarat Forensic Sciences University, Gandhinagar.

Other Seminar:

3)Infrared Spectroscopy & Stereochemistry by Prof. P.S.Kalsi

4)Principle Of Good Practice Quality Guidelines & Regulation by Dr. A.Ramkishan (CDSCO)

5)Clinical Research by Prashant Kale (Lambda)

6)Clinical Trials by Dr.Bhaswat.S.Chakraborty (Cadila)

7)Fluorescence Techniques & Its Application by Ashok.K.Mishra(IIT C)

8)Photo caging & Photo triggers by A.K.Singh (IIT Bombay)

9)Pharmacy Education by C.K.Kokate

TRAINING AND EXPERIENCE

I have taken training in Tablet, Capsule, Dry Syrup, Oral Liquid, Ointment, and Injection (Liquid & Dry Syrup) department at, Lincoln Pharmaceuticals limited.

Professional Experience: Research Associate – Bio analytical (June 2014-June 2016): -

One of the members of the Bio analytical team of Lambda Therapeutic Research LTD. an independent contract research organization dedicated to clinical research projects. Responsibilities include Method Development, Method Validation and Clinical sample Analysis.

Professional Experience: Research Associate – Bio analytical (June 2016-Jan 2018): -

One of the members of the Bio analytical team of Cliantha Research LTD. an independent contract research organization dedicated to clinical research projects. Responsibilities include Method Development, Method Validation and Clinical sample Analysis.

Professional Experience: Senior Research Associate–Bio analytical (Jan 2018-Oct 2020):

One of the members of the Bio analytical team of Lambda Therapeutic Research LTD. an independent contract research organization dedicated to clinical research projects. Responsibilities include Method Development, Method Validation and Clinical sample Analysis and Handle the Liquid Handling System (Automation).

Clinical Research Experience at Pharmazone:

Bioanalytical Monitoring

Around 15 monitoring of BA/BE, Phase I & Clinical End Point Projects

CRO Monitored/Audited

More than 04 CRO across the India

Regulatory Submission

USFDA(USA), CFDA(China),WHO,ANVISA(Brazil), CDSCO (India), EMEA(Europe), MHRA(UK), MOH(Turkey), TGA(Australia),HEALTH CANADA(Canada), JFDA(Japan)

PERSONAL DETAIL

Date of Birth : October 7th 1990

Father’s Name : Mr. Mahendrabhai B.Suthar

Languages Known : English, Hindi, Gujarati

Marital status : Married

Interests : Listening to Music, reading books, Playing cricket

REFERENCE

1)Prof. Y.K. Agrawal

Director of Institute of Research Development,

Gujarat Forensic Sciences University,

Gandhinagar

DELARATION

I hereby declare that the above-mentioned information is true and to the best of my knowledge.

Place: AHMEDABAD

Vivek M. Suthar

Permanent Address:

A/5, J.V.Park society, G.S.T. Crossing road,

Ranip, Ahmedabad-382460, Gujarat, India

Phone No: +91-909*******

Email ID: adj1w0@r.postjobfree.com

Present Employer:

Pharmazone in Clinical Research Department as Project Manager.

Contact this candidate