Quality Control Software
Resume:
ISHA TIWARI ****.********@*****.***
OBJECTIVE:
Seeks for a challenging position in an ever growing industry where my
expertise in the field of analytical chemistry can be utilized.
SUMMARY:
. Extensive experience in sample analysis using HPLC, GC, UV-Vis, FTIR,
AAS, NMR, Polarimeter, KF and other basic analytical tools.
. Expert in performing Dissolution and Disintegration Testing procedures
using USP Apparatus I & II, Disintegration Apparatus, BIO-DIS Apparatus
III.
. Proficient with Compliance Requirements within cGMP, safety and
regulatory environments.
. Experience in working with software applications like Electronic
Laboratory Notebook (ELN) and Laboratory Information Management System
(LIMS) in compliance with 21 CFR Part 11 guidelines.
. Developed Standard Operating Procedures (SOPs) for the maintenance of
analytical instruments and routine chemical analysis.
. Expertise in performing Wet Chemistry Techniques for the qualitative and
quantitative analysis of given samples.
. Adept in Separation and Purification of target compounds from the natural
and synthetic sample matrices.
. Significant experience in operating, validating, and troubleshooting
analytical instrumentation viz. FTIR, HPLC, GC, GC-MS, ICP-MS, AA, UV-Vis
etc.
. Implemented set analytical laboratory QA/QC Protocols.
. Experienced with method development and validation for starter with
excellent interpersonal and organizational skills.
. Excellent ability to multi-task and prioritize workload.
INSTRUMENTAL SKILLS
Practical lab work experience with analytical instruments like GC-MS, UV -
visible spectrophotometer, FTIR spectrophotometer, HPLC, GC, Polarimeter,
Atomic Absorption Spectrometer, USP Apparatus I & II, Dissolution Apparatus
and other basic analytical tools.
TECHNICAL SKILLS
Software Labtrack ELN, Labware LIMS, Agilent Chemstation,
Applications: Agilent Chemstore, SAS 9.1.2
Others: MS Office, MS Excel, MS Outlook, MS Power Point, MS
Publisher and other enterprise software.
ACADEMICS
. M.S. in Analytical Chemistry, 2010
Fairleigh Dickinson University, Madison NJ
GPA: 3.6
. B.S. in Pharmaceutical Science (B.Pharm), 2007
Rajiv Gandhi Technical University, India
GPA: 3.9
PROJECTS
. Molecularly Imprinted Polymers: Synthesized molecularly imprinted
polymers using glucose as a template by using official procedure. Also
analyzed the same using FTIR spectroscopic method.
. Drug Transporters and their role in Drug Interaction: Went through
various literatures and research papers to study the pharmacokinetics
aspects of drug-drug interactions mediated by Human Drug Transporters to
improve the bioavailability and efficacy of important range of drugs like
anti-viral and anti-cancer drugs.
SEMINARS
. Multifunctional Inorganic Nanoparticles for Imaging, targeting and
drug delivery.
. Electron capture dissociation of multiply charged protein cations.
. Imaging MALDI mass spectrometry using OCN as a matrix coating
system.
. Complete disulfide bond assignment of a recombinant IgG4
monoclonal antibody.
. Basics of Quantity Structure Activity Relationship (QSAR).
. Antibody mediated cancer prodrug therapy.
WORK EXPERIENCE:
Bal Pharma Ltd., India (Analytical Chemist, R&D Department - Mar '07-Jul
'07)
Bal Pharma is a fully integrated and leading Indian Pharmaceutical Company
specializing in Prescription drugs, Generic and OTC products, Intravenous
Infusion and Bulk Actives to improve the quality of life for patients by
providing them with products which are safe, effective, high quality and
affordable .
Responsibilities:
. Formulated laboratory SOPs for sample preparation and HPLC analysis of
APIs samples.
. Performed In-vitro dissolution testing of enteric coated tablets using
BIO-DOS Apparatus III.
. Performed assays based on new and existing methodologies using analytical
instruments like HPLC, UV-Vis, FTIR, AAS and Wet Chemistry Techniques.
. Developed and executed QA/QC Protocols for the maintenance and
troubleshooting of analytical instruments.
. Analyzed scientific data using statistical tools such as ANOVA.
. Involved in writing technical reports to document analytical methods and
transferring documented analytical methods to the QC department.
Pentagon Labs, Indore, India (QC Chemist - Sep'06- Feb'07)
Pentagon Labs Ltd. is a small scale pharmaceutical industry involved in
manufacturing of solid, semi-solid and liquid dosage form.
Responsibilities:
. Performed qualitative and quantitative analysis of samples using
chromatographic and spectroscopy techniques.
. Performed dissolution testing and disintegration testing on finished
solid dosage forms using USP Apparatus I & II and USP Disintegration
Apparatus respectively.
. Collaborated with research team in development of new analytical
techniques for the analysis of raw materials and finished products.
. Compile and analyze test information to determine process or equipment
operating efficiency and to diagnose malfunctions.
Alpa Laboratories Ltd., Indore, India (Inplant Trainee - June '06-
Aug' 06)
Alpa Laboratories is WHO-GMP and ISO 9001:2000 certified company involved
in manufacturing wide range of products that includes ethical drugs, OTC
and veterinary products in various formulations.
Responsibilities:
. Gained knowledge in manufacturing, quality control as well as quality
assurance of different pharmaceutical dosage forms.
. Worked on different analytical instruments like UV-Vis, FTIR
spectrometer, various chromatographic techniques etc.
. Study effects of various methods of processing, preserving, and packaging
on composition and properties of drugs.
. Prepared test solutions, compounds, and reagents for laboratory personnel
to conduct test.
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