Quality Control Manager
Resume:
RAJENDRA R. CHAMPANERI
Clifton, NJ 07011
Phone: 201-***-**** Email: *************@*****.***
www.linkedin.com/in/rajendrachampaneri
ANALYTICAL CHEMIST
Over twenty five (25) years of solid experience in pharmaceutical Quality
Assurance, Quality Control, Stability, Analytical methods development,
Validation, Instrumentation, Lab supervisor and Academic. Accomplished,
results-oriented individual with expertise in Pharmaceutical area.
Extensive hands on experience with HPLC, TLC, GC, TGA, UV/VIS, FTIR, IR,
AA, Fluorescence Spectrophotometer and Dissolution. Up-to-date knowledge of
cGMP and cGLP compliance requirements. Skilled at performing a variety of
routine and non-routine complex scientific tests utilizing laboratory
apparatus, including an analytical analysis and recording of data.
. Conducted analytical research and developed methods to test
pharmaceuticals products to established specifications.
. Performed analytical testing of R&D batches, Stability batches,
cleaning validation samples and generated final analysis report.
. Validated and transferred several products method for stability lab.
. Familiar with cGMP, FDA / ICH guidelines and OSHA regulations.
. Good analytical, administrative, organizational and supervisory
skills. Problem solving and decision making ability.
. Fast learner and computer literate. Flair of getting things done and
able to work efficiently and productively.
. Managed administrative functions in the absence of the Manager.
PROFESSIONAL EXPERIENCE
PURDUE PHARMA L.P. Totowa, NJ
2012 - 2013
Analytical Chemist: Quality Control, Stability
Analyzed solid dosage products, actives and complaints samples.
. Assisted groups with periodic self-inspections to ensure GMP, Safety,
EPA compliance and calibrations. (Compendia: USP, EP, BP and NF)
. Actively participated in groups as a data reviewer for evaluating
results, investigations, OOSs, non-conformance and for preparation of
stability reports.
. Managed investigations and troubleshooting and quickly resolved
testing problems.
. Self-trained for new products testing.
. Assisted analysts with troubleshooting and writing reports.
. Performed other duties as assigned.
RAJENDRA R. CHAMPANERI
Page 2
Phone: 201-***-**** Email: *************@*****.***
www.linkedin.com/in/rajendrachampaneri
NOVARTIS PHARMACEUTICALS, Suffern, NY 2000 - 2011
Senior Scientist: Quality Control, Stability
. As an analytical scientist, managed investigations; ensured
compliance with the appropriate regulations and guidelines; and
coordinated the work schedule including overtime.
. As a group leader reported to manager for overall team productivity,
investigations, special projects, existing systems, empowering and
training analysts for IDP's, constructive feedback.
. Scheduled tasks for analysts, reviewing and checking as a senior
data reviewer to ensure analytical integrity of data acquisition by
LIMS within GMP, SOP requirements for analytical method validation,
stability, quality control, calibration studies, checking cross-
references, specification limits.
. Provided assistance & guidance for investigations, LIR/OOS to
analysts. Assisting group with periodic self-inspections to assure
GMP compliance & for preparation of inspections.
. Actively participated in investigative issues related to compliance,
regulatory affairs, market recall, consumers (i.e. Pharmacy,
patient) complaints and internal investigations.
. Assisted in product transfer of analytical methods, Quality Control
documentation, and stability studies for released solid dosage
products.
. Performed analysis of Solid Dosage Form, actives, and complaint
samples, includes dissolution, extended release rate, assay, content
uniformity, degradants, chromatographic impurities, stability stress
studies.
. Proficient in usage of HPLC, Dissolution, UV/VIS and other data
acquisition systems. Managed various instruments used in analytical
laboratory.
. Trained new employees on LIMS, laboratory instrumentation,
analytical techniques and methods.
. Managed instrumentation IQ/OQ/PQ in the laboratory. Assisted group
with periodic self-inspections to assure GMP compliance.
. Performed other duties as assigned.
SIDMAK LABORATORIES, INC., East Hanover, NJ 1998 - 2000
Chemist: Analytical R&D
Performed new method development and validation of solid dosage products.
. Involved in method development of various
Pharmaceutical finished products.
. Analyzed finished products and generated reports.
. Maintained properly laboratory notebooks and reviewed
analyst's notebooks.
. Calibrated and maintained analytical equipment.
. Managed USP standards and chemicals.
. Performed other duties as assigned.
OTHER RELATED EXPERIENCE
POWER CONVERSION, INC., Elmwood Park, NJ
1990 - 1998
Supervisor : Quality Control Laboratories
Managed chemists and scheduled daily work to meet the due dates.
. Reviewed data analysis and generated final reports.
. Drafted test methods, method validation protocols and
reports.
. Employed and trained new chemists. Prepared and wrote
SOPs for analytical testing procedures.
RAJENDRA R. CHAMPANERI
Page 3
Phone: 201-***-**** Email: *************@*****.***
www.linkedin.com/in/rajendrachampaneri
. Maintained laboratory, calibrated equipments and
purchased chemicals and new equipments.
. Tested raw-materials and finished products using GC,
FTIR.TGA and KFT.
. Performed other duties as assigned.
B. K. M. Science College, Valsad, INDIA
1988 - 1990
Lecturer : Chemistry Department.
Teaching Chemistry at graduate level.
Bai Ava Bai High School, Valsad, INDIA
1984 - 1988
Lab Coordinator : Chemistry Lab.
Teaching Chemistry Practicals.
INSTRUMENTS
Waters Empower, Empower2 Chromatography Software with LIMS.
HPLC: Waters HPLC Data Acquisition system with LIMS.
Hewlett Packard HPLC1100 Series and GC 5900 Series.
UV/VIS, IR, FTIR, NMR, TGA, AA, KFT, FLUORESCENCE SPECTROPHOTOMETER
Manual / Automated Dissolution Apparatus I & II Units, Zymark MD and MD
plus.
Thin Layer Chromatography, pH-meter.
COMPUTER SKILLS
Microsoft Word, Microsoft Excel, Empower, Empower 2, LIMS, SAP, Q-DIS,
Lotus Notes
EDUCATION
Master of Science, Analytical Chemistry & Instrumentation, Stevens
Institute of Technology, NJ. USA.
Master of Science, Organic Chemistry with Synthetic Drugs, B.K.M. Science
College, INDIA
Bachelor of Science, Chemistry, B.K.M. Science College, INDIA
PROFESSIONAL DEVELOPMENT
Normal & Reversed Phase High Performance Liquid Chromatography, Novartis
Modern Chromatography in Analytical Chemistry, Chromak Research, Inc
Analyst Certification Program, Seton Hall University
Dissolution of Solid Dosage Testing, Sidmak Lab
FTIR Analytical Training, Power Conversion
Problem Solving For Improved Productivity
Critical Thinking Program
Innovation In Action
Social Style Series
Scientific Writing
Dear Sir / Madam
Enclosed is a copy of my resume; I would appreciate if you would take
time and go through it. I am seeking a position as an Analytical Chemist. I
have a strong background in Chemistry Laboratories that has been
strengthened over the years. I believe you will find that my qualifications
fit your requirements very well and my salary is negotiable.
I am excited about the position as an Analytical Chemist and the
ability to help your company succeed. Thank you in advance for your time.
Please do not hesitate to contact me if you have any questions. I would
appreciate the opportunity to review my qualifications in more detail. I
have listed below my contact information for your convenience.
Sincerely Yours,
Rajendra R. Champaneri
*************@*****.***
http://www.linkedin.com/in/rajendrachampaneri
Home Number: (973) 471 - 7351
Mobile Number: (201) 532 - 2736
Contact this candidate