This document is a resume for A.Gopalakrishna seeking a position in quality assurance or research and development in the pharmaceutical sector. He has over 3 years of experience in analytical R&D and 7 years in bioanalytical work. Currently he works as an Associate Scientist at G.V.K. Biosciences Pvt Ltd in Hyderabad. His expertise includes method development, validation, analysis of samples, and ensuring compliance with regulations like USFDA 21 CFR Part 11. He has experience with various analytical instruments and software.

1. A.GOPALA KRISHNA
Mobile:+91 9908880091
E-Mail: akshintala.gopal@gmail.com
Seeking Suitable position in the field of Quality Assurance/ Research & Development in Pharmaceutical Sector
SYNOPSIS
 A competent professional with over 3 years of experience in Analytical R&D, 7 years of experience in Bio analytical
section ,1 Year of experience in wet lab analysis known knowledge in Laboratory Information Management
System Pharmaceutical industry.
 Currently working with G.V.K. Biosciences Pvt Ltd., Hyderabad as Associate Scientist.
 Expertise with Industry Standards likeFDA’s Electronic Records and Electronic Signatures (ERES) rules and regulations
like 21 CFR part 11 effective for GMP applications in Pharmaceutical Industry.
 Profound knowledge about the USFDA, WHO, ANVISA, guidance documents regarding both phase type and BA/BE
studies, Solid Phase Extraction and Chromatographic principles; WATSON LIMS Software.
 Excellent organizational and problemsolvingskillswith proven ability to work through others to del iver results to the
appropriate quality and timeline metrics.
JOB OUTLINE
Since Jan’07 G.V.K.BIO Sciences Ltd, Hyderabad Associate Scientist
Aug’04 to Dec’06 Vimta Labs Ltd, Hyderabad Scientist
Jun’03 to Jul’04 Neuland Laboratories Ltd, Hyderabad Junior Chemist
Responsibilities
 Consistently meeting clients business needs.
 Method development
 Analysis of In-process, Finished product and Raw material samples.
 Responsible for Process R&D Samples Analysis.
 Facing regulatory & sponsor audits.
 Assisting analyst in handling & Calibration of LC-MS/MS.
 Involving in verification of study related data.
 Contributing in method development and method validation of various molecules.
 Reviewing and changing control of SOP’s as per Regulatory Requi rement.
 Investigating and applying new and existing techniques for the efficient Bio analysis of drugs and drug metabolites.
 Handling calibration and maintenance of various analytical instruments like HPLC, pH meter, analytical balances,
micropipettes, etc. as per GLP.
 Preparing of SOPs as per GLP.
 Looking after the requirements in our department for on-going projects planning accordingly.
 Working as member in safety Department.
 Following and maintaining cGMP, cGLP, SOP’s, health and safety policies.
 Planning and executing allocated Projects within the time lines as per the organization requirements.
ATTAINMENTS
 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 Bio analytical extraction techniques likeprecipitation, liquid liquid, solid phase extraction in
developing a method.
WORK SHOPS ATTENDED
 Attended trainingprogram for 3 days problem solvingin providingcomprehensivesolutionsfor lifescienceResearch
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" byMr. Nigel Dent, Fellow of Research Quality
Assurance (FRQA), and Director of Country Consultancy Ltd., UK.

2.  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.
 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 Bio analytical and Statistical data interpretation; technically sound knowledge on GLP & GCP
Guidance.
INSTRUMENTS HANDLED:
 LC-MS/MS API 2000, 3000, 3200, 4000, 5500 (Applied Bio-Systems)
 HPLC,UV,PH Meters, micro balances, analytical balances,
 LC-MS/MS Software: Empower-3, Analyst Software 1.4, 1.4.1, 1.4 .2, 1.5.1, 1.6.1 version, UPLC (Mass lynx 4.1)
Achievements awards and Rewards frompresent organization
.
 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.
 Received REWARD AND RECOGINITION AWARD 2012, for outstanding performance in Audit at GVK BIOSCIENCES
PVT. LTD.
 Received REWARD AND RECOGINITION AWARD for delivering the projects before the specified Timelines April 2014.
 Received award as a token of commitment for successful completion of five years of service at BIOSCIENCES PVT.
LTD.
IT FORTE
Office Automation: M S-Office 2000 and Internet Applications
Operating Systems:Windows 2000/XP, MS-DOS
ACADEMIA
2003 M.Sc. in Analytical Chemistry from Andhra University, AndhraPradesh
PERSONAL DOSSIER
Date of Birth: 15/06/1980
Address: Flat No.:104,Suprada Residency, Plot No.: 08 to 12, Near Aleap industries,Opposite Jagan
studio, Pragathinagar-11, Hyderabad-500090
Languages Known: English, Hindi and Telugu
Passport Details: passport no. - L8409871