Expert Details
Life Sciences, Lab IT Support & Validation
ID: 725344
Virginia, USA
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.
Array
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 f 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. 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.
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.
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 f 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.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1984 | Degree: MS | Subject: Pharmaceutical | Institution: South Gujarat University, India |
| Year: 1982 | Degree: BS | Subject: Chemistry, Physics | Institution: South Gujarat University, India |
| Year: 1984 | Degree: MS | Subject: Pharmaceutical | Institution: South Gujarat University, India |
| Year: 1982 | Degree: BS | Subject: Chemistry, Physics | Institution: South Gujarat University, India |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2006 to 2008 | Employer: Chrysalis Technologies | Title: IT Lab Support Engineer | Department: IT Lab Support |
Responsibilities: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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| Years | Employer | Title | Department |
| Years: 2005 to 2006 | Employer: Wyeth Consumer Research | Title: Lead Validation engineer | Department: IT Validation |
Responsibilities: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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| Years | Employer | Title | Department |
| Years: 2003 to 2005 | Employer: Frontage Labs | Title: Group Leader | Department: R & D |
Responsibilities: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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| Years | Employer | Title | Department |
| Years: 1993 to 1999 | Employer: Block Drug Company | Title: Sr. Scientist | Department: QC |
Responsibilities: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. |
|||
| Years | Employer | Title | Department |
| Years: 2006 to 2008 | Employer: Chrysalis Technologies | Title: IT Lab Support Engineer | Department: IT Lab Support |
Responsibilities: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. |
|||
| Years | Employer | Title | Department |
| Years: 2005 to 2006 | Employer: Wyeth Consumer Research | Title: Lead Validation engineer | Department: IT Validation |
Responsibilities: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. |
|||
| Years | Employer | Title | Department |
| Years: 2003 to 2005 | Employer: Frontage Labs | Title: Group Leader | Department: R & D |
Responsibilities: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. |
|||
| Years | Employer | Title | Department |
| Years: 1993 to 1999 | Employer: Block Drug Company | Title: Sr. Scientist | Department: QC |
Responsibilities: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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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 |
Additional Experience
| Marketing Experience |
|---|
| 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. |
Language Skills
| Language | Proficiency |
|---|---|
| Gujarati | Less than 10 % in writing, Speaking and reading about 50% |
| Hindi | Less than 20% |
| Gujarati | Less than 10 % in writing, Speaking and reading about 50% |
| Hindi | Less than 20% |