Quality Assurance Manager

NAME: Sachendra Sahu

Correspondence Address: ** A- Sector, Indrapuri, BHEL, Bhopal (MP)

Mobile: 097******** Email: *********@*****.***

Objective:

To work with an esteemed organization fully devoted in research and development work by utilizing my skill and caliber for the growth and expansion of the organization.

Academics:

Degree Institute/University Year of Passing Marks Obtained M Pharma

(Pharmacology) Guru Ghasidas Central University, Bilaspur. 2012 67% till 3rd semester

B Pharma

TIT College of pharmacy

Bhopal. 2010 66.17%

12th

MP Board 2004 76%

10th

MP Board 2002 70%

Clinical Research Training: Successfully completed Professional Diploma in Clinical Research (PDCR) program with following training topics:

Module – 1: Introduction to Pharmaceutical Medicine

The Drug Development Process

New Drug Discovery

Clinical Development of Drug

Essential Clinical Trial Documents

Clinical Trials Terminology

Module – 2: Good Clinical Practice (GCP) Foundations

History of GCP - milestones in the evolution of GCP

Principles of GCP

Applicable GCP Guidelines

Declaration of Helsinki

Clinical Study Process

The Management of Clinical Studies (Sponsor)

Ethics in Clinical Research

Informed Consent

Serious Adverse Event (SAE)

Challenges in the Implementation of GCP Guidelines

Biostatistics

Module – 3: Drug Regulatory Affairs

Overview of Regulatory Environment in USA, Australia, Europe and India

Clinical Trial Application Requirements in India

Import- Export of Clinical Trial Drugs in India

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.

IND/ANDA/New Drug Application

Module – 4: Roles and Responsibilities of Clinical Trial Personnel

Roles and Responsibilities of Sponsor

Roles and Responsibilities of Investigator

Roles and Responsibilities of ERB/IRB/IEC

Roles and Responsibilities of CRA /Monitor

Roles and Responsibilities of Auditor

Roles and Responsibilities of Clinical Research Coordinator or Site Manager

Roles and Responsibilities of CRO’s

Roles and Responsibilities of Regulatory Authorities

Roles and Responsibilities of Clinical Data Manager (CDM )

Roles and Responsibilities of Clinical Biostatistician

Research Projects : “Antiurolithiasis activity of Ficus mollis (Vahl) in albino rats”. Under the guidance of Dr Surendra. H. Bodhkhe (Asst. Professor), SLT Institute of Pharmaceutical Sciences, Guru Ghasidas central University, Bilaspur (C.G.) – 495 009

Achievment: GPAT – 2010 (Graduate Pharmacy Aptitude Test - 2010):

Qualified, organized by M.S Baroda Gujrat.

Fellowships Received:

Received scholarship from AICTE, New Delhi for being qualified in GPAT-2010 during the course of M. Pharm. degree.

Academic:

Paper Presentation on Animal Model for Antihypertensive Drugs in National Pharmacy week at RCP Bhopal.

Poster Presentation on Novel Drug for Treatment of Type-2 Diabetes.

Poster Presentation on Pharmacological activity and therapeutic use of cissampelos pariera a medicinal plant.

Publication:

Article title: A review on detail discussion of traditionaly used plant Cissampelos pareira. DOI: 10.1007/s13596-012-0067-1(Springer).

Industrial Training:

Ipca Laboratories limited, Ratlam (M.P.) Formulation Department (Manufacturing of Tablets & Syrups).

Extracurricular Activities:

Computer skill

Basics: MS office (Microsoft Word, Excel, Power point), Internet, IT, Windows, DOS, Foxpro, C-Language

NNS.

Interested Area:

Clinical trial and Pharmacovigilance.

R&D.

Preclinical and clinical studies.

Pharmacological screening of central nervous system.

Drug regularity affair.

Quality control and quality assurance

Soft Skills:

Quick and Logical learning ability

Excellent Communication Skill

Better Interpersonal Behavior

Ability to Work in a Team

References:

Dr. Surendra H. Bodakhe

Guru Ghasidas Central University, Bilaspur (C.G.)

Mob. 992-***-****, Email. *******@*****.***

Declaration

I hereby declare that the above mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above mentioned particulars.

Personal Information:

Name : - Sachendra Kumar Sahu

Father’s Name : - Mr. Munna Lal Sahu

Date of Birth : - 01 /07/86

Place of Birth : - Prithvipur, Dist. Tikamgarh (M.P.)

Marital Status : - Single

Sex :- Male

Language Known : - English and Hindi

Place Name

Bhopal Sachendra Sahu

M. Pharma

(Pharmacology)

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