Mallikarjuna rao resume dqa

MALLIKARJUNA RAO RESUME

1. Mallikharjuna rao N.
Hyderabad, India. Email: [email protected]
Cell : [phone]

OBJECTIVE

To work and grow in the challenging field of Quality Assurance or Compliance and
Audits to contribute my knowledge, skills and personnel commitment to my organization and
to continuously strive for professional excellence.

Summary of Experience (9.6 years in Formulations analysis, Documentation, inspections)

 Working as Scientist –II, Analytical R&D (Formulations) from December 2015 to till
date at NOVARTIS HEALTH CARE, Hyderabad.

 Worked as Research Scientist in Analytical R&D (Formulations) from August 2010
to December 2015 at MYLAN Laboratories, Hyderabad.

 Worked in Quality Control department from April 2009 to august 2010 at Yeluri
formulations, Hyderabad.

 Worked as Additional analytical chemist for one year during 2006-2007 at Trimurthy
formulations, kukatpally, Hyderabad. (Analysis of commercial samples using UV&
HPLC etc.).

WORK EXPERIENCE

 Executed the end to end responsibility of various project with Registration, clinical
and technical stability projects.
 Meet quality, quantity and timelines in all assigned projects of method validation and
clinical stability
 Various kind of documentation done in TEDI data base for example preparation of
SOP’s, Analytical methods, specifications, Stability reports, validation protocols and
reports, validation summaries etc.
 Review and approval of Clinical stability analysis reports for its correctness,
completeness and trending of stability data and review of analytical PDR data.
 Review and approval of release, retest (Clinical) batches for various projects.
 Involving in the OOS/OOT/Deviation investigation and its documentation and
reporting with respect to GMP norms.
 Responsible for frequent Auditing of Analytical Department as per self-inspection
plan and also to ensure compliance against previous audit observations.

2.  Understanding of Laboratory information system, to perform the various operations.
 Expert in OOS/OOE/OOT data management system with AQWA (Analytical Quality
Work Flow) application and handling of effective CAPA’s.
 Review and approval of Qualification document of various instruments and
equipment’s.
 Evaluation of the Stability data of drug products in different storage conditions by
analyzing the drug products as per stability schedule.
 Work experience with GLP environment or regulatory environment and Maintain
GLP and implement safety procedures while working in Lab.
 Handling project responsibility for timely and accurate delivery of analytical results
Formulation, Scale up Dept. etc.
 Determination of water content for API’S and finished dosage forms by Karl fischer
titrator, coulometer and loss on drying (LOD) methods.
 Calibration of assigned analytical instruments and Ensure that the calibrations of the
equipment’s are performed as per the schedule.
 To indent the required glass ware, chemicals and columns for the ARD projects and
other duties as assigned.
 Skillful compilation of various documents (protocols, reports) related to stability data,
dissolution release, impurities formed at different storage conditions and working
standards.
 Development and Validation of finished dosage forms.
 Conducting forced degradation studies and excipient compatibility Study.
 Evaluation of the Stability data of drug products in different storage conditions by
analyzing the drug products as per stability schedule and Preparation of stability
summary.
 Dissolution including multimedia profiling of finished dosage forms.
 Estimation of residual solvents by GC.
 Knowledge on data integrity and GLP aspects.
 Handling of regulatory queries.
 Work experience with GLP environment or regulatory environment.
 Handling project responsibility for timely and accurate delivery of analytical results to
Formulation, Scale up Dept. etc.
 Performing identification tests for various excipients.

3. INSTRUMENTAL TECHNIQUES EXPERTISE

 Alliance WATERS e 2695 HPLC with UV, VISIBLE-2489 & PDA-2998 Detector
 WATERS 717 plus auto sampler with 2487 dual absorbance detector
 WATERS ACQUITY UPLC
 SHIMADZU HPLC –Class LC-10 AT System with PDA detector
 UFLC SHIMADZU SPD-20A, LC-20AD
 AGILENT 1200 series HPLC with quaternary pump
 AGILENT technologies 1260 infinity HPLC system
 CAMAG HPTLC system
 JASCO FP-750 Spectrofluorometer
 JASCO V-530 UV/Vis- Spectrophotometer
 SHIMADZU UV-2450 UV-Visible spectrophotometer
 JASCO FTIR Spectrophotometer
 DISTEK 6300 dissolution tester with auto sampler 4300
 DISTEK 2100c dissolution tester
 VARIAN VK 7010 dissolution tester
 LABINDIA DS 8000
+
dissolution tester with auto sampler
 ELECTROLAB –TDT -08 L dissolution testers (USP)
 HANSON SR8 PLUS dissolution tester with auto sampler
 VARIAN –USP III dissolution tester with pump VK 750D
 SOTAX CP7 USP I,II and IV Dissolution tester (manual and autosampler)
 LABINDIA DS 14000 Dissolution test apparatus
 AGILENT TECHNOLOGIES GC SYSTEM with G1888 network headspace sampler
 METROHM 794 basic titrino with 703 Ti stand (KF tester)
 BROOKFIELD Viscometer
 ELICO Pvt. Limited, India, pH meter
 ELECTROLAB TDT - 08L Dissolution tester (USP)
 ALPHA FTIR Spectrometer.(opus software)
 AUTOPOL V polarimeter automatic

TECHNICAL SOFTWARE SKILLS

 Empower 2 and Empower 3
 Chromaleon
 TEDI
 Nugenisis- SDMS and LIMS
 MS office ( word, excel, Power point)
 GLIMS

4. ACADEMIC QUALIFICATIONS

 Ph.D. (Part time) from Jawaharlal Nehru Technological University (JNTUK) in
the faculty of Pharmaceutical Sciences, Department of Pharmaceutical Analysis
and Quality Assurance (2010-2017).

 M.Pharmacy with Pharmaceutical Analysis as specialization from The Tamilnadu
Dr. M.G.R Medical University, Chennai, with an aggregate of 72 % (2007-2009).

 MBA (Dual) in Pharma Marketing & Production Management from IIPM-Business
School, Lucknow with an aggregate of 76 % (2005-2007 through correspondence).

 PG Diploma in Pharmaceutical Chemistry from Madurai Kamaraj University with
an aggregate of 70% (2008-through correspondence).

 Masters Diploma in Pharmaceutical Management (MDPM) from Institute of
Pharmaceutical Education and Research (IPER), Pune (2009 - 2012 through
correspondence).

Diplomas covered under MDPM:
a) Diploma in Drug Regulatory Affairs
b) Diploma in Pharma Quality Control and Quality Assurance
Management
c) Diploma in Drug Laws

PROJECT WORKS

Ph.D.
Method development (stability indicating) and Validation using UV and RP-HPLC
for the estimation of selected drugs in bulk and their marketed formulations.
M.Pharmacy
Method development and Validation using UV, Spectrofluorimetry, HPTLC, and RP-
HPLC for the estimation of drug in bulk and tablet dosage forms.
PGDPC
An Interaction study of Gemifloxacin mesylate with DNA and concurrently administered
drugs by Spectrofluorimetry and RP-HPLC and application of RP-HPLC to estimate
Gemifloxacin mesylate from human plasma and formulation.
B.Pharmacy
A Study on extraction and identification of Alkaloids from Datura Stramonium.
MBA
Training needs analysis (at Virchow Biotech. Pvt. Ltd., Hyderabad).

PUBLICATIONS AND CONFERENCES

Journals published: 32 (National and International indexed and UGC approved).

Conferences attended: 05 (National and International).

DECLARATION

I hereby affirm that the particulars furnished are true to the best of my knowledge.

Date: 25.01.2018
Place: Hyderabad (N. Mallikharjuna rao)