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Expert in Life Sciences, Lab IT Support & Validation
Available for your Consulting and Expert Witness Needs
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Virginia (VA)
southeast
USA
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| Summary of Expertise: |
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Primary Expertise Areas:
(links show more experts in each area)
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Expertise Description: |
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drug analysis expert |
Worked as a group leader as well as R & D Sr.. scientist. Expertise in analytical method development and testing. Worked with NDA and ANDA products with different clients. Directly communicating with clients regarding progress and any problems in development stage. Involved in FDA inspection in 2 separate occasions. |
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drug development expert |
Work directly with clients in analytical method development for testing and perform their full robust tesing for that method and finally submitted FDA for their approval. |
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life science research expert |
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| Show Secondary and Basic Areas of Expertise |
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Virginia Beach, Virginia; Norfolk, Virginia; Chesapeake, Virginia; Richmond, Virginia; Newport News, Virginia; Hampton, Virginia; Alexandria, Virginia; Portsmouth, Virginia; Lynchburg, Virginia; and Suffolk, Virginia.
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Degree |
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Subject |
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Institution |
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1984
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MS
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Pharmaceutical
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South Gujarat University, India
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1982
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BS
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Chemistry, Physics
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South Gujarat University, India
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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2006 to 2008
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(Undisclosed)
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IT Lab Support
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IT Lab Support Engineer
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Serving as an informatics consultant to support laboratory instruments. Deployed and Configured majority of laboratory instruments like HPLC's, GC's, FLIR systems, BTG systems etc. Configured client server application Lab X for laboratory balances and HPLC. HPLC System mapped for network drive to export data into shared network so drive, so user can perform their calculation and generate reports.
Serving as an informatics consultant to desk side support. Deployed and Configured majority of office PC. Configured on network, Prepared system load set, installed custom software. Mapped network drive. Use Ghost 8.0 with Bart PE for system image. Configured client server scientific and engineering applications. Resolved majority of office related problems
Expertise on hardware on Lab and office PC. Updating system configurations, installing hard drive, memories and custom interface for system communications.
Enhanced Lab Support functionality to scientific and engineering laboratories for providing timely response to client for instruments and software identified technical problems for highly customized laboratories. Responding to approximately all Lab identified problem requests and resolved problems in timely manner.
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2005 to 2006
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Wyeth Consumer Research
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IT Validation
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Lead Validation engineer
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Played key role in the Validation effort for the Implementation of Waters Empower Build 1154 HPLC software.
Performed test coordinator duties for OQ/PQ testing phase.
Coordinate in writing traceability Matrices, OQ Summary report, OQ test scripts, PQ test scripts.
Authored of report design documents and developed custom reports using Empower software.
Developed custom fields and implements in custom reports.
Trained user for Empower software.
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2003 to 2005
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Frontage Labs
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R & D
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Group Leader
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Expertise in method development, method validation, writing protocols, methods, SOPs, and validation reports. Expertise in training the others. Develop SOP for backup and restoring data. Train other team member for instrument validation and IQ/OQ/PQ for HPLC, GC, FT-IR and Perkin Elmer UV-Vis spectrophotometer with 21CFR11 compliance software WinLab 4.1.
Performing troubleshooting and solving problem of widely used pharmaceutical instrument like HPLC, GC and Dissolution.
Schedule and assignment of work in coordination with lab manager. Taking care of stability chambers their qualification and maintenance. In charge of stability department for sample arrangement and work assignment. Preparing stability reports for accelerate stability/regular stability study. Reviewing Laboratory notebooks preparing COAs and reports. Troubleshoot for Varion HPLC and GC. Train department personnel on Varion Star HPLC system and Varion GC.
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to
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(Undisclosed)
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R & D
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Sr, Scientist
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Expertise in method development, method validation, writing protocols, methods, SOPs, and validation reports. Expertise in training the others. Develop SOP for backup and restoring data. Train other team member for instrument validation and IQ/OQ/PQ for HPLC, GC, FT-IR and Perkin Elmer UV-Vis spectrophotometer with 21CFR11 compliance software WinLab 4.1.
Performing troubleshooting and solving problem of widely used pharmaceutical instrument like HPLC, GC and Dissolution.
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1993 to 1999
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Block Drug Company
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QC
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Sr. Scientist
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Expertise in instrumental analysis and wet chemistry analysis of raw materials, in process samples and package finish products.
Expertise in testing oral dosage forms like tablets, capsules, and soft gelatin capsules. Also expertise in testing aerosol spray, electrolytes, sustained release capsules, dental products, creams, Rx and OTC drugs and household products.
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Licenses/Certifications
Waters Corporation – HPLC user and method development
Agilent Technologies – HPLC user and method development
Metter Corporation – TGA user training
SAP – User Training
Microsoft Office Suite – User training
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Served as a lead validation consultant for implementing client server Waters Empower HPLC software. Train user for executing and building custom reports. Authoring IQ/OQ/PQ documents. Coordinate in execution process of IQ/OQ/PQ part of validation. Generate deviation document for test script and procedures. Serving as an informatics consultant for deployment configuration and networking to support laboratory instruments in pharmaceutical and medical device lab.
Served as the Research and Development selective group leader resource responsible for expert training new staff in analytical techniques, instrumental analysis, troubleshooting techniques, instrument calibration and system validation and other job related requirements pertaining to activities in a GxP regulated R & D Laboratory.
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Responsible for perfectly managing software, hardware and network-related laboratory problems.
Expertise in method development, method validation, writing protocols, methods, SOPs, and validation reports. Expertise in training the others. Develop SOP for backup and restoring data. Train team members for instrument validation and IQ/OQ/PQ for HPLC, GC, FT-IR and Perkin Elmer UV-Vis spectrophotometer with 21CFR11 compliance software WinLab 4.1.
Expertise in instrumental analysis and wet chemistry analysis of raw materials.
Expertise in testing oral dosage forms like tablets, capsules, and soft gelatin capsules. Also expertise in testing aerosol spray, electrolytes, sustained release capsules, dental products, creams, Rx and OTC drugs and household products.
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As a member of the Intota consultant network,
Expert is a specialist who provides technical consulting to corporate, legal and government clients. Expert provides professional consulting as a Life Sciences Consultant, Lab IT Support & Validation Consultant. Expert may consult as an independent consultant or as a member of a consultancy, consulting company,
or consulting firm. Consultants service will be covered by a consulting contract.
Ask an expert initial screening questions and ask the experts services particulars, by simply submitting
an expert request.
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Intota experts can serve as expert witnesses or litigation consultants offering expert testimony, expert advice, litigation support,
forensic services, and related expert witness services. Expert can serve as an expert witness or litigation consultant in intellectual property (patent, trademark, trade secret, copyright),
product liability, and insurance matters. Expert may provide forensic expert witness testimony, litigation consulting services, forensic investigation,
and forensic testing if appropriate in litigation areas as a Life Sciences Expert Witness, Lab IT Support & Validation Expert Witness.
Intota provides attorneys and legal professionals the opportunity to ask an expert initial screening questions and
ask the experts services particulars by submitting an expert request.
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| Language Skills: |
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| Foreign Language |
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Description |
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Gujarati
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Less than 10 % in writing, Speaking and reading about 50%
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Hindi
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Less than 20%
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Informatics Professional with 20 years of laboratory instrumentation and validation experience in the medical device and pharmaceutical industry. Experienced in all phases of validation of computerized and automated systems according to industry standards, FDA regulations and guidelines. Specializing in data acquisition and management systems, business management systems, and laboratory instrumentation systems. Knowledge of 21 CFR Part 11, cGMP and Gamp4. Extensive knowledge in Waters Empower user and software validation, PE Win Lab, Agilent ChemStation, Agilent ChemStore and Perkin Elmer Total chrome HPLC software, Cispro administrator and laboratory system administrator. Dedicated, hard-working professional committed to client satisfaction.
Expert serves as a resource to
Intota Market Research Services
for customized marketing research in industries or areas related to
Life Sciences, Lab IT Support & Validation.
Experts are an invaluable source of overall industry insight as well as insight into specific companies and firms for
custom business to business (b2b) and industrial market research. Intota uses analyst and
consultant resources from Guideline whose Research Directors manage the research and analysis of the qualitative
and quantitative data as well as report writing for the custom studies. The methods and tools
used by Intota market research combine the insights of technical experts and industry insiders with secondary
research to provide the custom b2b and industrial market research you need.
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Expertise
