Quality Control Manager
Resume:
CHANDRA SEKHAR KUDUPUDI
* ***************@*****.***
Passport Number: L2857503
(: +91-986*******, 800-***-**** (Mobile)
H.No.3-5-87/0, G1,
C.B.R.Nilayam,
Vivekananda Nagar Colony,
Kukatpally, Hyderabad-500 072.
OBJECTIVE:
To pursue a challenging career in Quality Control for Pharmaceuticals,
which enables me to actively participate and provides an ample scope to
enhance my knowledge, skills, and career advancement and be recognized for
the contribution to the organization I am associated with.
CAREER SUMMARY
15 years experienced in Quality Control Department, who is full of
energy and enthusiasm; bringing a strong work ethic, a willingness to do
what it takes to get the job done with quality and attention to detail.
Flexible and professional communication skills and goal-oriented with the
maturity to be self-motivated and the time management skills to complete
work efficiently and within deadlines.
AREA OF INTREST
Quality Control,
Analytical R&D.
ACADAMIC RECORD
M.Sc Chemistry from M.K. University, India.
OTHER QUALIFICATIONS
Have been a Approved Analytical Chemist, Govt of Andhra Pradesh, India
since Sept 2005.
Management Representative for ISO 9001-2008 Since 2006.
Published 10+ Research articles in national and international Journals.
EMPLOYMENT HISTORY
> Working as Manager Quality Control for M/s. BIO-LEO ANALYTICAL LABS
INDIA PVT LTD, Hyderabad, India from Feb 2012 to till date.
> Worked as Quality Control Manager for M/s. CHANDRA LABS. Hyderabad,
India, from June 2005 to Jan 2012.
> Worked as Manager - QC/A R&D, for RA CHEMICALS&INTERMEDIATES PVT LTD
(RA CHEM PHARMA LTD). R&D in Prasanthinagar, Factory in Jaggayyapet,
India, from May 2004 to May 2005.
> Worked as Assistant Lab-In charge, for CHEMI LABS. Hyderabad, India,
from Aug 2000 to Apr 2004.
> Worked as Analytical chemist - QC, for TEENA Labs. Hyderabad, India,
from Aug 1998 to July 2000.
JOB PROFILE:
PROFESSIONAL SUMMARY
> Complete analysis of Packing materials, Raw materials and finished
products as per the USP, EP, BP, IP and In-house specification.
> Working standard profile.
> Dissolution profile for tablets capsules and pellets.
> Preparation of volumetric solutions their standardization.
> Performing analysis of API's by Reversed phase and Normal phase
Chromatography.
> Performing spectral analysis by IR and UV/VIS spectrophotometer.
> Troubleshooting and solving problems related to method and
instruments.
> Investigating the Deviations, Incidents and Out Of Specifications
(OOS) and Out Of Trend (OOT).
> Monthly and Daily Calibration of Instruments according to the
Calibration plan.
> Knowledge of TGA/GMP/GLP/SOPs and associated quality systems.
> Analyzed release Quality control samples including tablets, capsules,
suspensions and oral solutions.
> Developed, optimized and wrote analytical methods for assay,
impurities, dissolution, water content and cleaning verification of
new chemical entities.
> Analysis of the Organic Volatile Impurities by using Head Space GC and
GC/MS.
> Registration of inward, Retest, ATR materials through LIMS (Laboratory
Information Management System) and Documentation.
> Analyzed samples by UPLC, HPLC, GC-MS, GC, UV-VIS, IR and polarimeter.
TECHNICAL SKILLS
METHOD DEVELOPMENT:
> Well versed with HPLC Method Development for Products e.g.,
Unfinished/ Finished products using Chromatographic techniques i.e.,
HPLC/ UV, GC and Chemical analysis.
> Proficiency in Analytical Method Development in support of Formulation
Research & Development & Method transfer to Quality control
departments.
> Developing Analytical methods to help Quality control labs and trouble
shooting in day to day analysis.
> Conducting Technology Transfer & Demonstration of Analytical
Techniques to Quality Control Departments of subsidiaries units of
Organization. Ingredient Interference studies during product
Development.
METHOD VALIDATIONS:
ON UV-VIS SPECTROPHOTOMETER
> Assay Validation
> Simultaneous equation method
> Ratio absorption method
> Derivative methods
ON DISSOLUTION
> ODT/IR/DELAYED/SR/CR/FLOATING PROFILES
ON HPLC
> Related substances (Quantitative)
> Assay Validation
ON GC
> Residual solvents/organic volatile impurities
> Related substances (Quantitative)
And preparation of method validation protocols and validation reports
for various test methods (Assay & Related substances) For active
pharmaceutical ingredients, finished products and for intermediates
according to ICH Guidelines.
CALIBRATION OF INSTRUMENTS:
> Calibration of instruments and maintaining records.
> Calibration for HPLC, GC, UV, Polarimeter and FTIR, etc.
> Dispensing volume calibration and standardization for KFR
Autotitrator.
STABILITY STUDIES:
> Long term, Intermediate and Accelerated Stability studies of Drug
substance and Drug product.
> Analyzed stability samples (tablets and capsules) as required for
inclusion in Investigational New Drug applications (ICH Guidelines).
> Stability data generation and monitoring.
> Preparation of stability protocols and reports for various test
methods.
> Maintained and to check the performance of Stability Chambers.
INSTUMENTATION:
> HPLC-Extensive use of Agilent 1200 series with EZchrom Elite, Waters
Alliance with Empower-2, Shimadzu 2010 with LC-Solutions software and
Perkin Elmer with Total Chrom Navigator.
> GC-Shimadzu with GC-Solutions, Agilent 7890A with EZchrom Elite
software and Perkin Elmer with Total Chrom Navigator(Model: GC-Clarus
580, Head space - Turbomatrix 40).
> UV-Spectrophotometer (Make: Shimadzu, Perkin Elmer and Thermo
Scientific)
> FT-IR - Spectrometer (Make: Perkin Elmer Spectrum100,Shimadzu,Thermo
Scientific)
> AAS-spectrophotometer (Make: Analytik Jena, Shimadzu, Perkin-elmer)
> Autotitrator (Methrom)
> Polarimeter-( Make: Rudolph, Anton paar )
> Stability Chambers- Make: Cooling Incubator-NEWTRONIC, Walk-In
Humidity Chamber-NEWTRONIC and Humidity Chamber-LABTOP.
> Dissolution Test Apparatus - Make: Labindia, Electrolab, DBK
Instruments
> Bulk density, Melting point, Friability, Hardness tester,
Disintegration and Bursting strength apparatus.
REPORT WRITING AND DOCUMENTATION:
> Preparation of STP, SOP and Specifications etc. for Raw material,
Intermediate and Finished products
> Maintaining and peer-review documentation such as laboratory
notebooks, electronic data collection/storage software, instrument
logbooks, training records, etc.
> Ensure compliance of various quality measures such as, GLP, by
maintaining requisite documentation/ records. Preparing daily &
periodic laboratory reports for information, compliance & corrective
action.
> Writing/reviewing detailed documents like process and cleaning
validation protocols.
Personal Profile:
Name : CHANDRA SEKHAR.KUDUPUDI
Father Name : GANESWARA RAO
Permanent address : Palagummi (Village),
Amalapuram (Mandal),
East Godavari (Dist), A.P,
India - 533221.
Date of Birth : 07-08-1977
Religion : Hindu
Nationality : Indian
Marital status : Married
Languages known : Telugu, English & Hindi
REFERENCES
1.Dr.B.SRINIVASA REDDY
Technical Director,
RA CHEM PHARMA LTD,
Hyderabad, India,
Ph.+919*********.
2.Mr.V.KAMAL PRASAD
Technical Director,
M/s.DENISCO CHEMICALS PVT LTD,
Jeedimetla, Hyderabad, India,
Ph.+919*********.
Declaration: The above given information is correct as per the best of my
Knowledge.
Place: Hyderabad (CHANDRA SEKHAR KUDUPUDI)
Date:
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