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 Expert  725344

Expert in Life Sciences, Lab IT Support & Validation


Available for your Consulting and Expert Witness Needs

Virginia (VA)
southeast
USA
Education Work History Career Accomplishments Consulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

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.
 • 

drug analysis

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.
 • 

drug development

 • 

life science research


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.

Education:
Year   Degree   Subject   Institution  
1984   MS   Pharmaceutical   South Gujarat University, India  
1982   BS   Chemistry, Physics   South Gujarat University, India  

Work History:
Years   Employer   Department   Title   Responsibilities

2006 to 2008

 

Chrysalis Technologies

 

IT Lab Support

 

IT Lab Support Engineer

 

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.

2005 to 2006

 

Wyeth Consumer Research

 

IT Validation

 

Lead Validation engineer

 

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.

2003 to 2005

 

Frontage Labs

 

R & D

 

Group Leader

 

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.

to

 

(Undisclosed)

 

R & D

 

Sr, Scientist

 

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.

1993 to 1999

 

Block Drug Company

 

QC

 

Sr. Scientist

 

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.


Career Accomplishments:
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


Consulting Services:
Selected Consulting Examples:
  • 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.
  • 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.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Language Skills:
Foreign Language   Description
Gujarati   Less than 10 % in writing, Speaking and reading about 50%
Hindi   Less than 20%

Market Research:
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.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

 

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