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Namrata Kumari
Mob: 9723880249
Mail id: namrata.kumarrii@gmail.com
Total work experience: 03 years
Objective
An opportunity to work in a vibrant and exciting environment that hones my skill and to contribute
positively towards the growth and prosperity of the company and also to secure a position in this
ever-expanding field by virtue of my sincerity and dedication.
Experience:
Working at present: Bioequivalence center at Alembic Pharmaceutical Pvt. Ltd. Vadodara
Gujarat.
Designation: Research Associate at Quality assurance,
(From: Jul 2013 to till date).
Roles and Responsibilities:
Carrying out Review of Study protocols.
Carrying out Review of In-house SOPs.
Carrying out audit of ongoing study activities for screening, Check-in, Dispensing of
IPs, dosing activity.
Carrying out audit of Pharmacokinetics and Biostatistics phase of study.
Preparation of QA statement
Carrying out periodic system audit of in-house facility.
Carrying out Vendor’s audit.
Review the calibration Record of equipment’s.
Review the Study data as ICF, TMF, and CRF.
Providing on job training & SOP training to trainee.
Past Work Experience: Narayana Hrudayalaya Research center at Narayana Hrudayalaya
Hospitals Bangalore, Karnataka.
(From: Jan 2012 to Jan 2013).
Curriculum vitae
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Roles and Responsibilities:
Screening and enrollment of study subjects
Ensuring study is going on as per ICH- GCP Guidelines.
Adverse event and serious adverse event monitoring, reporting and follow up of study.
Study drug accountability.
Filling up CRFs, e-CRFs.
Maintaining the Study related log like prescreening log, subject enrollment log,
Temperature log.
Maintain the proper storage of the drugs tracking log according to the applicable regulatory
requirements.
Coordinate, Monitoring and audits visits.
Skills:
ICH-GCP guidelines
GLP
Indian GCP
Schedule Y
Educationand Qualification:
PG Diploma in Clinical Researchand pharmacovigilance .FromSysplex
Bio & Clinical solutions, Bangalore, Karnataka.
Computer Skill:
Proficiency in MS word, excel and Power Point.
Proficiency in Outlook, windows 7 and 8.
Strength:
Ability to maintain quality performance.
Excellent Presentation and report writing skill.
Flexible and adopt quickly new working environments.
Qualification Board/University Grade
M.Sc in Biotechnology Bangalore University, Karnataka 2nd class
B.Sc. Biotechnology Jiwaji University, Madhya Pradesh 1ST class
12th Bihar Intermediate Education Council 1ST class
10th Bihar School Examination Board 1ST class
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Highly organized can prioritize work schedules, manage time effectively and meet
deadlines.
Language Known: English, Hindi.
Personal Details:
Father name: Late Sri Chandra bhushan Prasad.
Date of Birth: 03 /01/1983.
Status: Single.
Permanent Address: Jai Prakash nagar, Khagaria, Bihar.
Present Address: G-9, Alembic colony, Gorwa, Vadodara , Gujarat.
Declaration: If you give me an opportunity to work at your company, I will put my maximum
effort at highest possible level for the growth of the company; I promise you that all the statements
made here are true to the best of my Knowledge.
Your Faithfully
