Quality Assurance Control

PRIYADARSHINI C. R.

+91-971******* ps.**apr @gmail.com

Current Address: Permanent Address:

#*/*, ********* ******, #*/4, Naickamar Street,

Vignesh Anush Apartments, West Mambalam, Vignesh Anush Apartments, West Mambalam,

Chennai, Tamilnadu, India, PIN - 600033 Chennai, Tamilnadu, India, PIN – 60 0033

Objective: To obtain a position of a Health care Professional in an organization where I am able to utilize my skills,

expertise & 2 years of experience in the field of healthcare product analysis, client handling, expanding medical

Laboratories, facility operations and field sales for the progress of the company.

Areas of Interest:

Cancer Pharmacology & Immunology

Novel Drug discovery to prevent cancer

Clinical research in the field of Cancer

Bio- Analysis

Education:

Year of

Qualification School/College Aggregate in %

passing

Kumararani Meena Muthiah College of Arts and Science,

2009 67%

M.Sc. Biotechnology

Chennai, India.

Dr.MGR Janaki College of Arts and Science for Women,

2007 67%

B.Sc. Microbiology

Chennai, India.

Sri Ramakrishna Mission Saradha Vidyalaya Model Higher

12th Standard 2004 85%

Secondary School, Chennai, India.

Sri Vidya Matriculation Higher Secondary School, Chennai,

10th Standard 2002 75%

India.

Techniques learnt during the Academia:

Immunology Microbiology

a) Immunoelectrophoresis a) Cell Plate counting

Counter Current Immuno Electrophoresis (CCIEP) b) Culturing of Microbes

Rocket Immuno Electrophoresis c) Gram Staining

d) Acid-Fast Staining

b) Immunodiffusion techniques

Ouchterlony Double Diffusion (ODD) e) Biochemical Tests for identification of Micro

Single Radial Immuno Diffusion (SRID) organisms

c) ELISA (Demonstration)

d) Differential Counting

e) RBC & WBC Counting

f) Blotting techniques - Southern blotting, Northern blotting & Western

blotting

Genetics Chromatographic Techniques

a) Restriction Fragment Length Polymorphism (RFLP) a) Affinity Chromatography

b) Polymerase Chain Reaction (PCR) b) Paper Chromatography

c) Isolation of DNA, RNA and Plasmid DNA c) Thin Layer Chromatography (TLC)

d) Column Chromatography

d) Restriction digestion techniques

Projects (M.Sc. Biotechnology):

Core Project:

Bio-informatics: Database Development from Elite Bioscience Foundation

• Developed a database for diseases pertaining to metabolic systems

• The database has information related to 45 metabolic disorders which includes genes and

proteins responsible for the disease.

• Software Languages used : PERL, Html and MySQL

Internship 1:

Underwent a Certificate Course on the following Bio -informatics Tools from Elite Bioscience Foundation under

guidance of Mr. Jashwanth Jenny

• FASTA

• BLAST

• RASMOL

• MODELLER 9V1 (Protein Modeling)

• Auto Dock 4 (Docking – Interactions between protein and Ligand molecule)

Internship 2:

Went through a o ne week Hands-on -training on “High Performance Liquid Chromatography” at Medispan

Limited, Chennai.

Professional Experience:

Jul 2009 - Jan 2010 Micro Therapeutic Research Labs Pvt. Ltd

Title: Trainee Research Associate – Quality Control (Quality Compliance team of the Bio

analytical department).

Technical Director: Kamal Singh Rauthan, M.Sc. Chemistry (Bio-Analytical Department)

• Quality control of the Bio-study raw data as per GLP/GCP Guidelines

• Preparation and reviewing of Standard Operating Procedures as per regulatory requirements

and conduct training of the same .

• Checking of generated Chromatographic Raw data as per US-FDA Guidelines.

• Initiate inspection and supervise the calibration/maintenance of all the equipments

(Chromatographic Column, Temperature Probe, Digital clock Slave, Thermo-hygrometer, etc.)

• Monitor completion of MV /Study activities (in-process) as per GLP and relevant SOP and

current regulatory requirements (Quality wise)

• Preparation of SOP’s for the “Determination of Bio-analyte (Single/Multiple Analytes)

concentrations in biological matrix (e.g. Human Plasma/Serum) By Ultra/High Performance

Liquid Chromatography – Mass Spectrometric Technique”.

• Preparation of Drug Profiles.

• Preparation of Method Validation and Bio-analytical Study reports.

Feb 2010 - Aug 2010 Micro Therapeutic Research Labs Pvt. Ltd

Title: Research Associate – Bioanalysis (Bio analytical department).

Technical Director: Kamal Singh Rauthan, M.Sc. Chemistry (Bio-Analytical Department)

• Preparation of reagents/Solutions for Method Development, Method Validation & Clinical Sample

Analysis.

• Method Development and Method Validation of Bio-Molecules to carry out Clinical sample

analysis of Generic Drugs as per ICH-GCP guidelines.

• Recording of Method Development trails.

• Submission Specific Method Validation of molecules.

• Preparation of Method Standard Operating Procedure (Method SOP) for the validated molecules.

• Preparation of Standard Operating Procedure (SOPs related to Bio analytical).

• Maintenance of Instruments/Equipments.

• Maintenance of working standards, Reagents, solutions & Electronic Balance.

• Frequent inspection of Logbooks and other documents for accuracy.

• Ensuring Safety of the Laboratory and maintenance of GLP environment.

• Frequent SOP and Safety & Quality Manual training of Junior staff as per schedule.

• Preparation of summary reports

• Developed methods for Tough molecules like Nitroglycerin, Ursodeoxycholic acid

Sep 2010 - Apr 2011 Micro Therapeutic Research Labs Pvt. Ltd

Title: Research Associate – Quality Assurance (Bio analytical division).

Team Manager: R. Abiraamasundari

• Quality Assurance of the Bio-study raw data as per GLP/GCP Guidelines

• Preparation and reviewing of Standard Operating Procedures (QA SOPs) as per regulatory

requirements and conducting training.

• Checking of Chromatographic and Clinical Raw data generated as per US-FDA & ICH-GCP

Guidelines.

• Initiate inspection and supervise the calibration/maintenance of all the equipments (Chromatographic

Column, Temperature Probe, Digital clock Slave, Thermo-hygrometer, etc.)

• Monitor completion of MV /Study activities (in-process) as per GLP and relevant SOP and current

regulatory requirements (Quality wise).

• Review of SOP’s for the “Determination of Bio-analyte (Single/Multiple Analytes) concentrations in

biological matrix (e.g. Human Plasma/Serum) By Ultra/High Performance Liquid Chromatography –

Mass Spectrometric Technique”.

• Review of Method Validation and Bio-analytical Study reports.

Skills:

Instruments worked on: Liquid Chromatography Tandem Mass spectrometry:

Ultra Performance Liquid Chromatography (UPLC)

• UPLC coupled with API 3000

• UPLC coupled with API 3200

• UPLC coupled with API 4000

• UPLC coupled with API 5500

High Performance Liquid Chromatography (HPLC)

• HPLC coupled with API 3000

• HPLC coupled with API 3200

• HPLC coupled with Waters Quattro Micro Mass

Softwares handled:

• Analyst 1.4.1

• Analyst 1.4.2

• Mass lynx 4.1

• Analyst 1.5.1

Calibration:

Regular calibration and Maintenance of the following instruments

• Shimadzu HPLC

• Waters Acquity UPLC

• Alliance HPLC

• Micro Balance

Audits & Accreditations went through:

• US Food & Drug Administration Regulatory Audit

• ANVISA (The National Health Surveillance Agency) – Brazilian Regulatory Audit

• AAFSAPS – French Regulatory Audit

• College of American Pathologist (CAP) Regulatory Audit

• NABL Accreditation

• ISO 9001:2008 Certification

• ISO 10015 Certification

Teaching Assistanceship:

Immunology

Taken seminar classes for undergraduate students during weekly sessions.

Has participated in conducting quizzes and preparing material for online lab sessions.

Declaration:

I declare that all the above information is true to the best of my knowledge and belief.

Priyadarshini C.R.

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