Quality Control Maintenance
Resume:
RADHIKA CHALAPAKA
Analytical Chemist
**************@*****.***
OBJECTIVE :
To utilize my pharmaceutical and chemist skills in an organization that will provide continuous
opportunities for mutual growth and advancement.
SUMMARY OF QUALIFICATIONS:
• Have 3 years of industrial experience as analytical chemist with Master’s Degree in
Pharmaceutical Chemistry.
• Experience in analyzing raw materials, in process and finished products using HPLC, GC,
UV-VIS, and Spectrophotometry.
• Well experienced in using Wet Chemistry techniques.
• Excelled in performing routine control and calibration and maintenance of IQ/OQ/PQ of
laboratory equipment
• Experienced in performing analysis in compliance requirements within c GMP, GLP, ICH
safety and regulatory environments.
• Communicating deviations and events to the supervisor which may affect the quality and
accuracy of the data.
• Results-oriented individual who views challenge as an opportunity and a motivated team
player capable of working independently with excellent communication, analytical, and strong
inter-personal skills.
INSTRUMENTATION SKILLS :
• HPLC -Perkin Elmer and waters (Agilent, Shimadzu –Empower, Totalchrom & waters)
• Gas Chromatography (Perkin Elmer-Empower,Totalchrom)
• Dissolution Apparatus(Venkel)
• UV-Visible Spectrometer (Shimadzu)
• FTIR & ATR (Perkin Elmer, Thermonicolet)
• Atomic Absorption Spectrophotometer (shimadzu)
• Karl Fischer equipment (DL-53 Titrator)
• PH meter, Density meter, Automatic Refractometer, %Moisture Analyzers, Melting point
Apparatus, Centrifuges, Turbidimeter, Tintometer, TOC Analyzer and Viscometer.
SOFTWARE SKILLS:
• Experienced with Empower, Totalchrom(HPLC, Class VP, GC)
• Microsoft Office programs ( Outlook, Word, Excel and Power point)
EDUCATION
Master’s in Pharmaceutical Sciences (Pharm. Chemistry )
•
Aug 2008 – Dec 2010
Fairleigh Dickinson University, Madison, NJ, USA
RELAVENT GRADUATE COURSES:
Advanced Pharmaceutical Analysis, Industrial Pharmacy, Bio pharmaceutics, Principles
of Pharmacology/Medicinal Chemistry, Product and Process Validation, Heterocyclic
Chemistry, Physical Organic Chemistry
Bachelor’s in Pharmacy
•
Aug 2004 – Apr 2008
Acharya Nagarjuna University, Guntur, AP, India
RESEARCH WORK:
Submitted a thesis titled “Phase solubility studies of Aceclophenac and Pyroxicam”. The
solubility and dissolution capacities of the drugs were enhanced by using different
concentrations of PEGs over other agents.
Undergraduate project Work: Enhancement of Dissolution rate of Glimepiride by using
Solid Dispersion Technique.
PROFESSIONAL EXPERIENCE
Employer: Mirror Pharmaceutics LLC, Fairfield, NJ
Role: Analytical Chemist
Aug 2011 – Present
Mirror Pharmaceutics LLC is a State of the Art Pharmaceutical Development and
Manufacturing Company designed to develop and manufacture NDA, ANDA, and OTC Solid
Oral Drug Products (Regular and Schedule Drugs II-V) for the US and Global Markets.
Roles & Responsibilities:
Performing method developments, method validations and method transfers of assay,
•
dissolution and related substances of different products.
Validated the method for Linearity, Accuracy, Precision, LOD and LOQ.
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Analyzing raw-materials, in-process, finished and stability products under cGMP
•
guidelines.
Performing TOC and Conductivity of water and water sampling.
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Performing routine control, calibration and maintenance of laboratory equipment
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Preparation of STP's, Protocols and various validation reports.
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Documentation in laboratory notebooks according to the cGMP guidelines and
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maintaining electronic records.
Excellent laboratory skills including the knowledge of safe handling of chemicals and
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equipment.
Performing vendor qualification studies.
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Ordering and maintenance of USP reference standards and working standards.
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Maintenance of stability chambers, monitoring and recording of temperature and
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humidity periodically.
Employer: Chantilly BioPharma LLC, Chantilly, VA
Role: QA Associate Jun
2011 – Aug 2011
Chantilly BioPharma (CBL) is engaged in the development, manufacturing,
commercialization, licensing and marketing of its proprietary technologies and products
for a wide range of pharmaceuticals.
Roles & Responsibilities:
Preparation of SOP's, STP's, and Protocols.
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Responsible for the reviewing and issuing of batch records, laboratory notebooks and log
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sheets etc
Performing in-process checks in the manufacturing area.
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Sampling and submitting of samples to be tested to Quality Control department.
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Reviewing laboratory data and reporting the discrepancies to the supervisor.
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Loading the stability chambers for stability testing of products and retrieving samples on
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timely manner.
Client: Avon, Suffern, NY
Role: QC Chemist
Feb 2011 – Jun 2011
AVON is a leading global beauty company and one of the world's largest direct sellers, and has
nearly $11 billion in annual revenue.
Roles & Responsibilities:
Experienced in qualitatively analyzing sunscreens, preservatives, impurities and actives
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in cosmetic products using HPLC and GC.
Excelled in analyzing creams, lotions, suspensions, lipsticks and powdered cosmetics.
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Performed solubility studies of various waxes using a variety of organic solvents.
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Work involved in the analysis of raw materials by using IR, UV-VIS spectroscopy, TLC,
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DSC and Wet chemistry techniques.
Ordering of laboratory chemicals, maintaining the MSDSs and C of As.
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Contact this candidate