Quality Assurance Manager

RAJESH ERANNA.K

Rajesh Eranna K mob.990*******

Email id :-************.****@*****.***

Beside biocon

Krishnappa bulding

Hebaguddi

Bangalore

Presently Working as a quality assurance manager in HEALTH CARE GLOBAL

(HCG) BANGALORE IINSTITUTE OF ONCOLOGY BANGALORE

OBJECTIVE:

To pursue a challenge and exciting position in the fields of Pharmaceutical

Quality Assurance and Quality Control and work with at most enthusiasm

while being resourceful, innovative and flexible.

WORK EXPERIENCE:

Worked as Trainee - QUALITY ASSURANCE, Global pharmatech, Hosur, from

June 2007 - June 2008.

Worked as EXECUTIVE - MICROBOLOGY, Wintac Ltd, Bangalore, from June

2008 to june2011.

Working as a quality assurance manager in HEALTH CARE GLOBAL (HCG)

BANGALORE IINSTITUTE OF ONCOLOGY

ACADEMIC QUALIFICATION:

Advance programme diploma in clinical research

> M.Sc in Microbiology from Gulbarga University,Gulbarga, Karnataka

passed with 53.00 % during the year 2007

> B.Sc (Chemistry, Zoology Microbiology) from L.V.D. College, Raichur

Gulbarga University, passed with 67.86% during the year 2005.

Field of interest - clinical operation and Pharmocovigilance

KNOWLEDGE OF CLINICAL RESEARCH--:

1.ICH-GCP

a.efficacy

b.safety

c.quality

d.mulidisciplinary

2.pharmacodyanamics

Pharmacokinetics

Pharmacoeconomics

Bio availability and bio equivalence studies

Clearance

JOB PROFILE:

. I have worked oncology project in clinical research phase 11 and

shortly we are ready

To start phase 111

. I am undergoing two more projects upon oncology

. 1.fdg which is used for uptake of cancer

. 2.f-choline - which is used for prostate cancer

. Still two more projects under progresses

. Preparing protocols

. Getting the radioactive material from the states by custom clearance

. Recently I have faced GEHC audit for our new project with GE

people and we

successfully we have passed the audit

. Environmental Monitoring: Routine monitoring of controlled environment

by Active, Surface sampling and personnel monitoring. Non-viable air

borne particulate matter monitoring of controlled environments using

airborne particle counter.

. Water system: Routine analysis of potable water, purified water, water

for injection for total Microbiological count and pathogens.

. Media preparation: Regular procurement, preparation, sterilization,

storage and utilization of the media.

. Microbial limit test: Aseptic sampling of Raw Materials, water and

routine analysis of MLT of Raw materials, semi-finished products,

primary packing materials etc.

. Maintenance of cultures: Procurement, sub-culturing (3 passages) and

maintenance of cultures.

. Bacterial Endotoxin test: BET by gel clot technique using LAL reagents

for WFI, Raw Material & finished products.

. Particulate matter test: Routine particulate testing of SVP, LVP and

Eye drops using microscopy and HIAC liquid particulate testing system.

. Sterility test: Routine testing of finished products (SVP, LVP, Eye

drops, LDPE &HDPE containers, closures and in- process samples.).

. Validations: Validations of Autoclave & Dry heat sterilizer.

. Validation of Sterility test, Microbial limit test, Preservative

efficacy test, Container closure integrity for other products.

. Validation of Autoclave & Dry heat sterilizer.

. Involved in the Validation of aseptic broth fill trial carried out for

SVP, LVP and Ophthalmic filling lines.

. Preparation of Standard Operating Procedures.

. Looking into customer audit compliance with regarding to microbiology

and taking corrective action plans.

. Reviewing of filled BMRs.

.

. HANDLING HPLC AND ANALYZING SAMPLES

. HANDLING GAS CHROMATOGRAPHY AND ANALYZING SAMPLE

. CALIBRATING THE DOSE CALIBRAOR

. HANDLING THIN LAYER CHROMATOGRAPHY AND ANALYZING SAMPLES

. HANDLING GAMA SPECTROPHOTOMETER AND ANALYZING THE SAMPLE

INSTRUMENTAL ANALYSIS:

> MILLIPORE air sampler (Millipore Air Tester).

> MET ONE air borne particle counter.

> HIAC liquid particulate Counting system.

> Vitek 2 compact. (API Kit)

> Electrophoresis set up-Protein and DNA/RNA.(Genei and Biotek).

> UV-Vis spectrophotometer (Secom am).

> Gel Documentation system (hero lab).

RESEARCH PROFILE:

> Worked on Project water pot ability test by MPN Method

> Isolation, Characterization Identification and antibiogram of milk

micro flora of Gulbarga region

> Survey of milk Micro flora of Gulbarga Region

COMPUTER KNOWLEDGE:

> Basics.

PERSONAL PROFILE:

Name : Rajesh Eranna. K

Sex : Male

Date of Birth : 09.03.1981

Martial Status : Single

Native : Raichur, Karnataka

Nationality : Indian

Languages Know : Kannada, Hindi, English &Teulgu,Tamil.

Address for Correspondence : Rajesh Eranna K

H.No.9-2-25, Maddipet

Raichur-584 101

REFERENCE:

Dr.S.M.Gaddad Dr.C.T.Shivannaver

Professor, Senior Lecturer,

Deparment of Microbiology, Deparment of Microbiology,

Gulbarga University Gulbarga University

Gulbarga -585106 Gulbarga -585106

E-mail:*********@**********.*** E-

mail:*********@**********.***

Ph: 084**-******(0), Ph: 084**-******(0)

DECLARATION:

I here by declare that the information furnished here is true to the best

of my knowledge.

Place: Gulbarga Rajesh Eranna K

Date:

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