Manager Quality Assurance

THE PROPOSAL

I, A.GOPALA KRISHNA M.Sc. Analytical chemistry from Andhra univarsity

having the desire to fly as an excellent Bioanalytical professional of

BA/BE clinical research sky.

Presently performing as Manager in the Bio analytical section of

GVKBIOSCIENCES PVT LTD., HYDERABAD.

Received award as a token of commitment for successful completion of five

years of service at BIOSCIENCES PVT. LTD.

Received REWARD AND RECOGINITION AWARD for outstanding performance April

2008.

Received Outstanding performance award 2011, for leadership & commit to

excel at GVK BIOSCIENCES PVT. LTD.

Shown interest in various work shops and seminars regarding scientific and

non scientific on Clinical and Bioanalytical research oriented during my

professional career.

Thorough knowledge about the ICH-GCP, USFDA, WHO, ANVISA, guidance

documents regarding both phase type and BA/BE studies.

As I am an enthusiastic and hardworking Bio analytical professional

interested to implement my knowledge and skill in the new scientific

environment for the progress of me and to the organization.

A.GOPALA KRISHNA

HYDERABAD

Curriculum Vitae

A.GOPALA KRISHNA,

Flat No.:104,

Suprada Residency

Plot No.: 08 to 12

Near Aleap industries, Ph:990-***-****,

Opposite Jagan studios,

Pragathinagar-11. Email: **********.*****@*****.***

Hyderabad-500090

OBJECTIVES

Dynamic Manager with 10 years of solid experience in Bioanalytical

division, BA/BE studies, combined with strong administrative management

skills, aim to respond to new challenges and contribute to effective

bioanalytical research within your professional developing environment.

Willing to work in a team, which utilizes my skills and knowledge for the

benefit of both the company and me. Have great thirst to sneak into the

paths of success by involving in activities within a professional

developing environment.

Professional Experience:

At present I am working as Manager at G.V.K.BIO Sciences Ltd, Hyd

since Jan 2007 to till date.

Previously I Worked As Scientist at Vimta Labs Ltd, From August 2004

to December 2006.

Previously I Worked As Juniour Chemist at Neuland Laboratories Ltd,

From (June '2003 to July 2004)

Professional Skills:

> Preparation of SOPs as per GLP.

> Bio-analytical method development and its validation as per GLP and

ICH guidelines.

> Knowledge on Solid Phase Extraction.

> Knowledge in Chromatographic principles with special emphasis on HPLC

and LC-MS/MS.

> Capability of investigating and applying new and existing techniques

for the efficient Bio analysis of drugs and drug metabolites.

> Calibration and Maintenance of various analytical instruments like

HPLC, pH meter, analytical balances, micropipettes, etc. as per GLP.

> Theoretical and practical knowledge in performing analytical tests

using LC-MS/MS, UV-VIS spectrophotometer and physical and chemical

tests of pharmaceutical products.

> Proficient in literature survey and interpretation of data.

> Ability to learn new techniques quickly; work independently;

commitment to quality, excellent interpersonal and communication

skills.

. Follow and maintain cGMP, cGLP, SOP's, health and safety policies.

. Excellent project management skills and enjoys problem solving.

. Excellent communication and negotiation skills.

JOB PROFILE

. PROJECT INCHARGE

. Consistently meeting clients business needs.

. Facing regulatory & sponsor audits.

. Diligently assisting analyst in handling & Calibration of LC-MS/MS.

. Effectively involving in verification of study related data.

. Effectively contributing in method development and method validation

of various molecules.

. Literature survey of various drug molecules.

Instruments Handled:

* LC-MS/MS API 2000,3000,3200,4000,5500(Applied Bio-Systems)

* LC-MS/MS Software : Analyst Software 1.4,1.4.1,1.4.2,1.5.1,version

* Having experience in handling of LIMS Software.

* Creating Mater assay in LIMS.

* Study Designing in LIMS

* Allocating persons for the study in LIMS

* Creation of project batch in LIMS

* Importing the data in LIMS

* Quantifying the results in LIMS

* Performing repeats identification in LIMS

* Accepting repeats samples in LIMS

* Performing mandatory Repeats in LIMS

Education qualification profile:

* M.Sc (Analytical Chemistry ) ( 2001-2003 )

Andhra university, Andhrapradesh

* B.Sc.(M.P.C) (1998-2001)

S.K.B.R Collage, Andhra university, Andhrapradesh

Achievements

. Hands on experience in calibration and Handling

UPLC-MS/MS (ultra performance liquid chromatography-mass

spectrometry)

LC-MS/MS (API 5500,API-4000, API-3200, API-3000, API-2000)

. Faced audits(regulatory & sponsor):

>USFDA -4

>ANVISA -4

>WHO -3

> sponsor audits - app 10 No.

. Diligently involved in method development and validation of various

molecules (ex:photo sensitive molecule, temperature sensitive

molecule)

. Effectively involved in bioanalytical extraction techniques in

developing a method.

. Consistently supported in preparation of method validation protocol,

method validation report and method SOP of respective molecules as per

USFDA, ANVISA formats.

. Effectively involved in Bioanalytical and Statistical data

interpretation.

. Technically sound knowledge on GLP & GCP GUIDANCE

Work shops attended:

. Attended training program for 3 days problem solving in providing

comprehensive solutions for life science Research by LABINDIA LIFE

SCIENCES held in Delhi(GURGON) In Dec 2008

. Attended problems solving introduction of UPLC- MS 1Day Tanning

program held at HYDERABAD in Hotel Kathriya.

. Attended workshop on "Principles of Good Laboratory Practices" by

Mr. Nigel Dent, Fellow of Research Quality Assurance (FRQA), and

Director of Country Consultancy Ltd., UK.

. Attended 3Days Training program held at Green park hotel on

Creativity and Innovation in problem solving By DR. SUJATHA Krishna

rao M.B.A,SDES(OXON),Ph.D. psycho.

Software Skills:

Office Automation : M S-Office 2000 and Internet

Applications

Operating Systems : Windows 2000/XP, MS-DOS.

Personal Profile:

Name : A.GOPALA KRISHNA

Father's name : A.VENKATESWAR RAO

Marital Status : Married

Sex : Male

Nationality : Indian

Languages Known : English, Hindi,and Telugu

(A.GOPALA KRISHNA)

Contact this candidate