Vera Edelstein has over 30 years of experience leading quality assurance, validation, project management and consulting roles in pharmaceutical, financial services and telecommunications industries. She has expertise in computer system validation, quality processes, and regulatory compliance, especially 21 CFR Part 11. She has managed projects from concept through implementation and retirement, with budgets up to $30 million.
Cyndie Beacham has over 28 years of experience in IT testing, including 15 years experience managing tests and defects using tools like ALM Quality Center, ClearQuest, and Rally. She has worked as a test consultant, analyst, planner and manager for companies in various industries, helping to improve testing processes by creating test plans and cases, advising on requirements traceability, and producing defect analysis reports. Her experience spans testing types like system, integration, user acceptance, and regression testing.
The summary provides information on Kristine Kowalski's background and experience in quality assurance, validation, and regulatory affairs. She has over 13 years of experience in these fields, including serving as the Validation Manager at Cody Laboratories for over 4 years. She has extensive experience leading validation projects, writing documentation, ensuring compliance, and mentoring others. Her skills include validation, cleaning validation, computer system validation, and regulatory submissions.
Jackson Lee has over 15 years of experience leading quality assurance teams and managing projects. He has a strong background in software testing, quality control, and process development. Some of his accomplishments include achieving zero system failures for 5 years and successfully integrating two complex networks. He is highly skilled in testing, programming, project management, and communication.
Process Certification Implementation Presentationmdmilward
The document summarizes Hamilton Sundstrand's implementation strategy for process certification (Six Sigma) at their Windsor Locks, Connecticut facility. Key aspects included establishing a process certification council and steering committees to oversee the effort. Standard work, procedures, systems and infrastructure were developed to support data collection, analysis and reporting. Training programs were implemented to develop black belts and green belts across internal operations and supplier sites. The results were reported as reductions in cost of poor quality, variation and improvements in customer satisfaction scores and certification levels.
Hamilton Sundstrand implemented a Process Certification program based on Six Sigma to reduce variability and control processes. Key aspects included:
1) Defining critical product characteristics and milestones for certification.
2) Developing standard work procedures and classifications to identify and select important product characteristics consistently.
3) Establishing systems like a database to track key product characteristics, collect statistical data, and report on progress.
Todd Groshong has over 20 years of experience managing complex product development and deployment across several industries. He has a track record of leading cross-functional teams through new product development, introduction, and life cycle management. His areas of expertise include project management, engineering, reliability, process improvement, and agile software development. He is currently seeking new opportunities where he can apply his leadership skills and experience developing and delivering innovative technology solutions.
The document provides a summary of Tribhuwanachoubey's experience and qualifications. It summarizes his experience supporting NERC and WECC compliance standards audits at Southern California Edison, developing electronic repositories for compliance documentation and relay settings, and chairing the IEEE Foothill Society PES chapter where he delivered talks on various power engineering topics.
This document provides a summary of Cedric D. Green's qualifications, including over 20 years of experience in quality assurance roles. He has a bachelor's degree in business administration and has worked at several companies in QA lead and analyst roles testing software applications. His experience includes testing web, client-server, and mainframe applications across different industries.
Cyndie Beacham has over 28 years of experience in IT testing, including 15 years experience managing tests and defects using tools like ALM Quality Center, ClearQuest, and Rally. She has worked as a test consultant, analyst, planner and manager for companies in various industries, helping to improve testing processes by creating test plans and cases, advising on requirements traceability, and producing defect analysis reports. Her experience spans testing types like system, integration, user acceptance, and regression testing.
The summary provides information on Kristine Kowalski's background and experience in quality assurance, validation, and regulatory affairs. She has over 13 years of experience in these fields, including serving as the Validation Manager at Cody Laboratories for over 4 years. She has extensive experience leading validation projects, writing documentation, ensuring compliance, and mentoring others. Her skills include validation, cleaning validation, computer system validation, and regulatory submissions.
Jackson Lee has over 15 years of experience leading quality assurance teams and managing projects. He has a strong background in software testing, quality control, and process development. Some of his accomplishments include achieving zero system failures for 5 years and successfully integrating two complex networks. He is highly skilled in testing, programming, project management, and communication.
Process Certification Implementation Presentationmdmilward
The document summarizes Hamilton Sundstrand's implementation strategy for process certification (Six Sigma) at their Windsor Locks, Connecticut facility. Key aspects included establishing a process certification council and steering committees to oversee the effort. Standard work, procedures, systems and infrastructure were developed to support data collection, analysis and reporting. Training programs were implemented to develop black belts and green belts across internal operations and supplier sites. The results were reported as reductions in cost of poor quality, variation and improvements in customer satisfaction scores and certification levels.
Hamilton Sundstrand implemented a Process Certification program based on Six Sigma to reduce variability and control processes. Key aspects included:
1) Defining critical product characteristics and milestones for certification.
2) Developing standard work procedures and classifications to identify and select important product characteristics consistently.
3) Establishing systems like a database to track key product characteristics, collect statistical data, and report on progress.
Todd Groshong has over 20 years of experience managing complex product development and deployment across several industries. He has a track record of leading cross-functional teams through new product development, introduction, and life cycle management. His areas of expertise include project management, engineering, reliability, process improvement, and agile software development. He is currently seeking new opportunities where he can apply his leadership skills and experience developing and delivering innovative technology solutions.
The document provides a summary of Tribhuwanachoubey's experience and qualifications. It summarizes his experience supporting NERC and WECC compliance standards audits at Southern California Edison, developing electronic repositories for compliance documentation and relay settings, and chairing the IEEE Foothill Society PES chapter where he delivered talks on various power engineering topics.
This document provides a summary of Cedric D. Green's qualifications, including over 20 years of experience in quality assurance roles. He has a bachelor's degree in business administration and has worked at several companies in QA lead and analyst roles testing software applications. His experience includes testing web, client-server, and mainframe applications across different industries.
- Over 15 years of experience in quality engineering, project management, and manufacturing engineering with a focus on electronics, electrical systems, medical devices, and telecommunications.
- Extensive experience leading quality initiatives, audits, product development, and supplier quality to improve business performance, customer satisfaction, and compliance with standards.
- Holds multiple certifications in quality engineering, Lean Six Sigma, auditing, medical devices, electronics manufacturing, and Agile project management.
- Education includes a master's degree in project management and bachelor's degrees in electrical engineering.
First of a two-part article published in Pharmaceutical Technology magazine in December 2005.
Part 1 describes facility and equipment design review, validation project organization and planning, and validation master plan development.
Brian D. Wilson has over 30 years of experience in engineering leadership roles spanning product development, project management, and team leadership. He has an MS in Mechanical Engineering from Stanford University and a BS in Mechanical Engineering from USC. Currently he is Senior Director of Engineering Excellence & Optimization at ASME, and previously held director roles at Bio-Rad Laboratories and Beckman-Coulter, where he led cross-functional teams in developing complex diagnostic instrumentation and launched new product platforms. He has a proven track record of successfully developing and commercializing innovative products on time and within budget.
- Celeste Fralick is a Principal Engineer and Chief Data Scientist at Intel with over 25 years of experience. She leads an Analytics Center of Excellence and has developed complex algorithms and predictive models that have generated over $2B in revenue.
- Her experience spans several roles in engineering, quality assurance, operations, and data science at Intel, Medtronic, National Semiconductor, Texas Instruments, and Fairchild Semiconductor.
- She holds a PhD in Bioengineering from Arizona State University and has authored patents and publications in analytics, medical devices, reliability, and quality systems.
Brian D. Wilson has over 25 years of experience in engineering leadership roles spanning product development, project management, and team leadership. He holds advanced degrees from Stanford and USC and has managed cross-functional engineering teams of up to 65 people. Currently he is Senior Director of Engineering Excellence and Optimization where he provides strategic guidance and manages complex projects.
The RCM analysis process consists of 7 steps to determine the best maintenance strategy for an asset. It involves gathering basic information, performing a failure modes and effects analysis, identifying risks of failure, determining maintenance actions to mitigate risks, analyzing costs and benefits, compiling results, and generating final reports. The process is supported by software that facilitates information sharing and automatic report generation.
Jerry Schwab has over 20 years of experience in quality engineering, software testing, and project management. He has worked at 3M in various roles related to quality assurance, testing, and service support for projection and interactive display products. His experience includes facilitating firmware upgrades, recovering revenue through product repairs, and improving production line yields. He is proficient in quality processes, statistical analysis, software development, and project management methodologies.
Joseph Vault has over 30 years of experience in engineering, regulatory compliance, and program management across multiple industries. He currently runs his own regulatory consulting firm and has previously held senior roles at Ives Envision, Proconex, Honeywell, and CB Ives providing technical, validation, and quality management services to pharmaceutical and medical device clients. He has extensive experience developing and managing validation programs, performing regulatory assessments and remediation, and training clients on inspection readiness.
Tami Strickland has over 30 years of experience in project management, software development, and avionics systems. She has a background in computer science and is certified in project management, Lean Six Sigma, and holds an MBA. She has successfully managed complex multi-million dollar projects across various industries. Currently, she works as a senior project manager focusing on IT projects involving software deployment, system integration, and hardware configuration.
This document is a resume for Prem Kumar Papabathini seeking a position as a QA Lead/Manager. It summarizes his 13 years of experience in software testing, including 6 years as a Test Manager. It provides details on 5 key projects he has worked on in roles such as Test Manager, Test Lead, and Test Analyst for clients like Bank of Montreal, National Grid UK, CP Rail, AT&T, and ING-VYSYA. It also lists his technical skills and certifications.
Nisha Varghese is a senior QA analyst and test lead with 9 years of experience in healthcare, travel, and retail domains. She has worked on various projects for Carefirst BCBS including their private exchange platform and reports for product setup changes. Her responsibilities include requirements analysis, test planning, task allocation, test oversight, reporting, and client management. She is proficient in testing methodologies, tools like ALM, and platforms like SharePoint, Lotus Notes, and mobile.
This document is a resume for Mina N. Meawad, who has 15 years of experience in technical management roles including system test, software development, project management, and system integration. She is skilled in developing project plans, balancing priorities, and resolving issues. She is recognized for high quality deliverables that meet timelines and budgets. Mina has a track record of building effective teams and partnerships with stakeholders. Her technical skills include program and project management, software development, cloud migration, requirements engineering, and testing.
Anthony Bordley has over 20 years of experience in software quality assurance, testing, project management, and business analysis. He has led QA teams and developed testing processes for companies like VWR International, Apex Systems, and Bank One. Bordley has expertise in a variety of testing techniques including manual testing, test automation, defect tracking, and risk assessment. He is proficient in many programming languages, testing tools, and project management methodologies.
Muneer Khan has over 23 years of experience in Qatar's major oil and gas industry, working for Qatar Petroleum since 1992. He has extensive experience managing inspection database systems and implementing risk-based inspection programs. As team leader, he was responsible for managing the implementation of inspection management systems and providing post-implementation support. He has strong skills in systems analysis, design, development, training, and maintenance and has worked independently as a support analyst.
Ginger Hawkersmith has over 25 years of experience in software quality assurance, testing, project management, and systems engineering. She currently works as a QA Project Test Engineer for Siemens PLM Software, where she develops and executes tests to ensure software meets requirements. Previously, she worked for various defense contractors such as SAIC, DRS Technologies, and QTEC, providing quality engineering, requirements management, and process improvement services for projects involving military aircraft, avionics, and weapons systems.
The document is a resume for Vinay Kulkarni, an SAP consultant with over 12 years of experience in SAP modules including PS, CS, PM, and FICO. He has worked as a solution architect, project manager, and lead consultant on implementation, upgrade, and support projects for companies in various industries. His technical skills include SAP R/3, ECC, Windows operating systems, and MS Office applications.
A leading bank required a testing partner to conduct data migration and system integration testing for an upgrade from PeopleSoft 8.0 to 8.9 in a limited time span. Hexaware provided comprehensive implementation and upgrade services using testing tools and processes to ensure a successful upgrade. Key services included a testing accelerator kit, a data comparison tool, test processes, templates, and planning to efficiently complete testing within timelines and allow the bank to meet aggressive go-live dates.
- The document provides a summary of Clemmie Crocker's experience and qualifications, including over 28 years working in leadership, management, project management, quality assurance, and auditing roles. He has extensive experience ensuring compliance with ISO 9001, AS9100, and other quality standards.
- Crocker has a Bachelor's and Associate's degree from Embry Riddle Aeronautical University and various technical certifications. He has worked for several defense contractors performing tasks like quality management, configuration management, auditing, and ensuring safety and procedural compliance.
- His experience includes over 15 years of project management, 8 years of experience with ISO 9001 and AS9100 auditing and management, and 28 years of experience in
John Dermody is a Project Management Professional (PMP) certified project manager with over 15 years of experience managing complex projects for Hewlett-Packard. He has a proven track record of driving operational efficiency and realizing millions in cost savings. Dermody holds an MBA and has managed projects globally, including overseeing a lucrative partnership with Japanese OEM partners generating $300-500M annually. He is proficient in Agile and traditional project management methodologies.
Jimmy Vale has over 6 years of experience in validation engineering for the pharmaceutical industry. He has extensive expertise in computer system validation, process validation, FDA regulations including 21 CFR Part 11, and validation documentation like validation plans and reports. He is proficient in testing tools like Mercury Quality Centre and Quick Test Professional. Currently he works as a Validation Analyst at Eisai, where he is leading the retrospective validation of a legacy inventory management system.
Srinivas Pendam has over 15 years of experience in information technology as a certified SAS and mainframe professional. He has worked as a senior software consultant, business data strategy analyst, and software analyst. Pendam has extensive experience designing, developing, implementing, and supporting complex software systems across various industries.
- Over 15 years of experience in quality engineering, project management, and manufacturing engineering with a focus on electronics, electrical systems, medical devices, and telecommunications.
- Extensive experience leading quality initiatives, audits, product development, and supplier quality to improve business performance, customer satisfaction, and compliance with standards.
- Holds multiple certifications in quality engineering, Lean Six Sigma, auditing, medical devices, electronics manufacturing, and Agile project management.
- Education includes a master's degree in project management and bachelor's degrees in electrical engineering.
First of a two-part article published in Pharmaceutical Technology magazine in December 2005.
Part 1 describes facility and equipment design review, validation project organization and planning, and validation master plan development.
Brian D. Wilson has over 30 years of experience in engineering leadership roles spanning product development, project management, and team leadership. He has an MS in Mechanical Engineering from Stanford University and a BS in Mechanical Engineering from USC. Currently he is Senior Director of Engineering Excellence & Optimization at ASME, and previously held director roles at Bio-Rad Laboratories and Beckman-Coulter, where he led cross-functional teams in developing complex diagnostic instrumentation and launched new product platforms. He has a proven track record of successfully developing and commercializing innovative products on time and within budget.
- Celeste Fralick is a Principal Engineer and Chief Data Scientist at Intel with over 25 years of experience. She leads an Analytics Center of Excellence and has developed complex algorithms and predictive models that have generated over $2B in revenue.
- Her experience spans several roles in engineering, quality assurance, operations, and data science at Intel, Medtronic, National Semiconductor, Texas Instruments, and Fairchild Semiconductor.
- She holds a PhD in Bioengineering from Arizona State University and has authored patents and publications in analytics, medical devices, reliability, and quality systems.
Brian D. Wilson has over 25 years of experience in engineering leadership roles spanning product development, project management, and team leadership. He holds advanced degrees from Stanford and USC and has managed cross-functional engineering teams of up to 65 people. Currently he is Senior Director of Engineering Excellence and Optimization where he provides strategic guidance and manages complex projects.
The RCM analysis process consists of 7 steps to determine the best maintenance strategy for an asset. It involves gathering basic information, performing a failure modes and effects analysis, identifying risks of failure, determining maintenance actions to mitigate risks, analyzing costs and benefits, compiling results, and generating final reports. The process is supported by software that facilitates information sharing and automatic report generation.
Jerry Schwab has over 20 years of experience in quality engineering, software testing, and project management. He has worked at 3M in various roles related to quality assurance, testing, and service support for projection and interactive display products. His experience includes facilitating firmware upgrades, recovering revenue through product repairs, and improving production line yields. He is proficient in quality processes, statistical analysis, software development, and project management methodologies.
Joseph Vault has over 30 years of experience in engineering, regulatory compliance, and program management across multiple industries. He currently runs his own regulatory consulting firm and has previously held senior roles at Ives Envision, Proconex, Honeywell, and CB Ives providing technical, validation, and quality management services to pharmaceutical and medical device clients. He has extensive experience developing and managing validation programs, performing regulatory assessments and remediation, and training clients on inspection readiness.
Tami Strickland has over 30 years of experience in project management, software development, and avionics systems. She has a background in computer science and is certified in project management, Lean Six Sigma, and holds an MBA. She has successfully managed complex multi-million dollar projects across various industries. Currently, she works as a senior project manager focusing on IT projects involving software deployment, system integration, and hardware configuration.
This document is a resume for Prem Kumar Papabathini seeking a position as a QA Lead/Manager. It summarizes his 13 years of experience in software testing, including 6 years as a Test Manager. It provides details on 5 key projects he has worked on in roles such as Test Manager, Test Lead, and Test Analyst for clients like Bank of Montreal, National Grid UK, CP Rail, AT&T, and ING-VYSYA. It also lists his technical skills and certifications.
Nisha Varghese is a senior QA analyst and test lead with 9 years of experience in healthcare, travel, and retail domains. She has worked on various projects for Carefirst BCBS including their private exchange platform and reports for product setup changes. Her responsibilities include requirements analysis, test planning, task allocation, test oversight, reporting, and client management. She is proficient in testing methodologies, tools like ALM, and platforms like SharePoint, Lotus Notes, and mobile.
This document is a resume for Mina N. Meawad, who has 15 years of experience in technical management roles including system test, software development, project management, and system integration. She is skilled in developing project plans, balancing priorities, and resolving issues. She is recognized for high quality deliverables that meet timelines and budgets. Mina has a track record of building effective teams and partnerships with stakeholders. Her technical skills include program and project management, software development, cloud migration, requirements engineering, and testing.
Anthony Bordley has over 20 years of experience in software quality assurance, testing, project management, and business analysis. He has led QA teams and developed testing processes for companies like VWR International, Apex Systems, and Bank One. Bordley has expertise in a variety of testing techniques including manual testing, test automation, defect tracking, and risk assessment. He is proficient in many programming languages, testing tools, and project management methodologies.
Muneer Khan has over 23 years of experience in Qatar's major oil and gas industry, working for Qatar Petroleum since 1992. He has extensive experience managing inspection database systems and implementing risk-based inspection programs. As team leader, he was responsible for managing the implementation of inspection management systems and providing post-implementation support. He has strong skills in systems analysis, design, development, training, and maintenance and has worked independently as a support analyst.
Ginger Hawkersmith has over 25 years of experience in software quality assurance, testing, project management, and systems engineering. She currently works as a QA Project Test Engineer for Siemens PLM Software, where she develops and executes tests to ensure software meets requirements. Previously, she worked for various defense contractors such as SAIC, DRS Technologies, and QTEC, providing quality engineering, requirements management, and process improvement services for projects involving military aircraft, avionics, and weapons systems.
The document is a resume for Vinay Kulkarni, an SAP consultant with over 12 years of experience in SAP modules including PS, CS, PM, and FICO. He has worked as a solution architect, project manager, and lead consultant on implementation, upgrade, and support projects for companies in various industries. His technical skills include SAP R/3, ECC, Windows operating systems, and MS Office applications.
A leading bank required a testing partner to conduct data migration and system integration testing for an upgrade from PeopleSoft 8.0 to 8.9 in a limited time span. Hexaware provided comprehensive implementation and upgrade services using testing tools and processes to ensure a successful upgrade. Key services included a testing accelerator kit, a data comparison tool, test processes, templates, and planning to efficiently complete testing within timelines and allow the bank to meet aggressive go-live dates.
- The document provides a summary of Clemmie Crocker's experience and qualifications, including over 28 years working in leadership, management, project management, quality assurance, and auditing roles. He has extensive experience ensuring compliance with ISO 9001, AS9100, and other quality standards.
- Crocker has a Bachelor's and Associate's degree from Embry Riddle Aeronautical University and various technical certifications. He has worked for several defense contractors performing tasks like quality management, configuration management, auditing, and ensuring safety and procedural compliance.
- His experience includes over 15 years of project management, 8 years of experience with ISO 9001 and AS9100 auditing and management, and 28 years of experience in
John Dermody is a Project Management Professional (PMP) certified project manager with over 15 years of experience managing complex projects for Hewlett-Packard. He has a proven track record of driving operational efficiency and realizing millions in cost savings. Dermody holds an MBA and has managed projects globally, including overseeing a lucrative partnership with Japanese OEM partners generating $300-500M annually. He is proficient in Agile and traditional project management methodologies.
Jimmy Vale has over 6 years of experience in validation engineering for the pharmaceutical industry. He has extensive expertise in computer system validation, process validation, FDA regulations including 21 CFR Part 11, and validation documentation like validation plans and reports. He is proficient in testing tools like Mercury Quality Centre and Quick Test Professional. Currently he works as a Validation Analyst at Eisai, where he is leading the retrospective validation of a legacy inventory management system.
Srinivas Pendam has over 15 years of experience in information technology as a certified SAS and mainframe professional. He has worked as a senior software consultant, business data strategy analyst, and software analyst. Pendam has extensive experience designing, developing, implementing, and supporting complex software systems across various industries.
Dipesh Shah has over 10 years of experience as a QA Lead working on projects for clients like CIBC and RBC, with a focus on testing applications built using Pega, Ecourier, and other tools. He has expertise in test planning, execution, defect tracking, and managing teams of testers. The document provides details on his skills, qualifications, work history and accomplishments on various banking software projects.
Lisa Lazenby has over 25 years of experience in quality analysis, testing, and business analysis. She specializes in process improvement through change management methodologies. She has extensive experience with test methodologies and technologies across mainframe, client-server, and web-based systems. Lazenby has a strong background in healthcare claims processing and has worked on projects involving HIPAA, EDI, and system integrations.
The document provides a resume for Tammy L. Clark, who has over 15 years of experience in software quality assurance, test project management, requirements specification, test analysis, and test design. She has extensive experience developing test plans and cases, executing both manual and automated tests, analyzing results, and tracking defects using various testing tools. Her background includes testing projects in various domains for companies like SunTrust Bank, The Home Depot, Time Warner Cable, and BellSouth Entertainment.
Harvinder Singh has nearly 20 years of experience in project management, software development, and testing. He has managed teams of up to 70 people and led projects involving requirements gathering, design, development, testing and implementation. Some of his responsibilities have included planning projects, monitoring schedules and budgets, ensuring quality standards are met, and mentoring team members. He has deep experience in domains like telecommunications, networking, billing and cloud computing.
Dipesh Shah is a seasoned IT professional with over 10 years of experience in QA team management. He has extensive experience leading testing for banking software projects at TCS and RBC, including implementations of Pega and other applications. His responsibilities included developing quality plans, test cases, defect tracking, and reporting. He has strong skills in test automation, databases, and programming languages.
Dipesh Shah is a seasoned IT professional with over 10 years of experience in QA team management. He has extensive experience leading testing for banking software projects at TCS and RBC, including implementations of Pega and other applications. His responsibilities included developing quality plans, test cases, defect tracking, and reporting. He has strong skills in test automation, databases, and programming languages.
Jagadeesh Babu has over 5 years of experience in software testing, including functional testing, agile testing, test planning, and test execution. He has expertise in testing mainframe, web, and mobile applications for clients in banking, insurance, and healthcare. Jagadeesh is proficient with testing tools like ALM, QTP, and Selenium and databases like Oracle, DB2, and SQL. He is certified in ISTQB foundations and agile testing methodologies.
Sakthi Raghu has over 14 years of experience in quality assurance testing for financial services and information technology projects. He has expertise in test automation tools like Selenium and manual testing strategies. Currently he is a QA Manager at JP Morgan Chase where he leads testing efforts, facilitates agile processes, and manages releases.
This document provides a summary of Narasimha Murthy Kapa's qualifications and experience. It includes his contact information, education, and over 11 years of experience in software testing, test management, and development. He has expertise in automation testing tools like QTP, LoadRunner, and RPT. His experience includes testing applications in domains like banking, healthcare, and data warehousing. He is currently working as an Automation Consultant for JP Morgan Chase, where his responsibilities include test planning, coordination, and leading testing activities.
Victor Colon has over 12 years of experience in computer validation, software quality assurance, and business process improvement. He has skills in building QA infrastructure, managing verification teams, and training users. Victor is effective at seeking solutions to problems in a people-oriented way, resulting in higher productivity and job satisfaction. He has experience leading projects in computer system validation, testing, and process automation at various pharmaceutical and financial companies.
- Faruk O. Syed has over 20 years of experience in engineering management, quality assurance, and project management. He has a background in electrical engineering and business administration.
- He has worked for several Fortune 500 companies, specializing in quality systems, process improvement, auditing, and ensuring regulatory compliance.
- Syed has extensive technical expertise and certifications in areas such as Lean Six Sigma, ISO standards, medical device software, and engineering project management. He aims to accurately design systems while meeting objectives for customer satisfaction, quality, and growth.
Sarala has over 6 years of experience in software quality assurance, testing, and support roles. She has expertise in manual and automated testing, test plan development, defect management, and experience with testing tools like QTP, LoadRunner, and Quality Center. She has worked on a variety of applications including mainframe, web, healthcare, and financial software. Her background includes roles testing desktop, online, and mobile applications for financial and healthcare clients.
Paul Marples has over 17 years of experience in information technology with expertise in QA test management, testing, project management, and business analysis. He has a proven track record of analyzing problems, simplifying processes, and finding innovative solutions. His technical skills include testing tools, programming languages, databases, and Microsoft products. He has worked in roles such as test lead, project manager, and business analyst for companies such as TELUS, IBM, and Coca-Cola.
This document provides a summary of Krishna Mohan E.S.V.'s experience and qualifications. He has over 10 years of experience in quality analysis, validation, testing, and performance engineering for various applications. He is proficient in test planning, automation, and has expertise in tools like LoadRunner, JMeter, and Quality Center. Krishna Mohan has worked on projects in various domains for clients like MetaVante Corporation, Q-Capital Strategies, Quintiles, IBM, Volt, Tata Consultancy Services, and F. Hoffman-La Roche.
This document provides a summary of Robin Peterson's professional experience and qualifications. Robin has over 6 years of experience as a Validation Analyst in the life sciences industry. Robin has extensive experience with validation lifecycles, interacting with clients to define requirements, and generating validation documentation. Robin has worked at several pharmaceutical companies, leading validation projects and ensuring compliance with FDA regulations.
Timothy Sisk has over 15 years of experience in software testing, management, and implementation. He currently works as a Quality Assurance Lead, coordinating testing efforts for internally developed and third party applications, including testing for ICD10 and a third party EHR system. Previously he held roles as a Senior Quality Assurance Analyst and Software Quality Assurance Analyst, developing and executing test plans and procedures.
Kenithe Biggs has over 10 years of experience in IT management, project management, quality assurance, and software/product support. He is seeking a career as an IT professional utilizing his skills in quality assurance, support, and management. He has experience managing teams, improving processes, and ensuring high customer satisfaction and low post-release issues.
Jayanthi Sureshkumar is an experienced senior software QA analyst and automation tester with over 20 years of experience in testing, project management, and team leadership. She has expertise in manual and automation testing across several industries. She is proficient in many testing tools and technologies and holds an ISTQB certification.
Similar to V Edelstein Resume Progenics 12 10 (20)
1. Vera Edelstein
382 Central Park West, Suite 9K
New York, NY 10025
Phone: 646-369-4171; e-mail: VEdelstein@aol.com
SUMMARY
Experienced leader, executive, manager, consultant, negotiator, and planner. Expert in information
systems, process quality assurance, computer systems validation, project management, change
management, strategic and business planning in multi-industry settings, such as telecommunications,
pharmaceuticals, and finance. Skilled in improving organizations' effectiveness, efficiency, profitability, and
bringing products and services to the market. Work effectively and communicate well with all levels of
management, possess strong interpersonal skills, and outstanding organizational skills. Managed multiple
projects with staff of 5 to 40, and operating budgets of $10 million and multi-million capital budgets.
PROFESSIONAL EXPERIENCE
Progenics Pharmaceuticals, Inc., Tarrytown, NY 5/07 - Present
Consultant (5/07 – 11/07) Sr. Manager Computer Systems Validation
Responsible for corporate-wide validation and verification of computer systems
Guided and/or developed validation/verification documentation including
developing/revising SOPs for the following projects:
• WinNonlin implementation of Equity Edge 7.0, GreatPlains 8.0,
• Core LIMS – initial, upgrades ADP, SAS 8.0, Oracle 9i)
• Talent Management Suite (TMS) • SAS 9.2 upgrade
• Rave-IxRS (EDC hosted) • ADP (web) upgrade
• DocCompliance- Clinical Study • Great Plains v. 10 upgrade
Report Repository • Equity Edge v. 8.0 upgrade
• DocCompliance – Certificate of • SuccessFactors
Analysis • FoundationIP
• DocCompliance - Performance • ClinTrial upgrades/enhancements
Enhancement and Upgrade v.4.4 • ClinTrace upgrades/enhancements
• System Retirement (older versions
VeraQual Associates, Inc., New York, NY 1/93 – 5/07
President, Management Consulting
[ ISO9000, IEEE, SEI/CMM, cGMP, cGLP, cGCP, 21 CFR Part 11, GAMP, Six Sigma, CRM, Siebel, TQM,
SDLC, QA, PMO, BPR, JAD, RAD, MS Project, PVCS, WinRunner, SAS, Oracle, Windows, 2000/NT/XP,
SUN Solaris, Visual Basic, HTML, JAVA, WinNonlin, abap, C/C++, client/server. HP, UNIX, NT, Lotus
Notes, Websphere, Documentum, DocCompliance, SAP, MES, I-Planet, UDB, UML, Rational, VPN]
For Fortune 500 companies (telecommunications, pharmaceutical, financial services) provided consultation
that improved efficiency, effectiveness, and significantly reduced cost:
6/05 – 4/07
Cytogen- Princeton, NJ, Provided assessment for a Documentum validation project
• Conducted audit of applications and business needs
• Provided assessment what validation needed to implement Documentum
Therics - Princeton, NJ Medical device certification project
• Provided analysis to certify to ISO 9001 or ISO 13485
• Provided gap analysis between what existed and what needed to be done to certify to ISO 13485
Geritrex –Mt. Vernon, NY, OTC pharmaceutical manufacturing – 21CFR Part 11 assessment
• Provided an assessment of compliance of the manufacturing to the FDA regulations
• Provided an assessment of compliance to 21CFR Part 11
2. QA/Validation Manager for CFR Part 11 projects [ISO9000, IEEE, SEI/CMM, cGxP,GAMP eCTD]
Clinical Systems /infrastructure (US, Japan) Eisai 7/03 – 6/05
• eDMS (Documentum) – provided validation and quality assurance guidance/auditing in the IQ/OQ/PQ
phases of the project; reviewed, revised and created SOPs (Change Management/Control, Managing
Physical/Logical Security, Maintaining Validated Server/Client, Backup/Restore/Disaster Recovery, Help
Desk, etc.) for CFR Part 11 project.
• Clintrial/dsNavigator integration– prepared Validation Plan and Validation Summary Report,
reviewed/created pre/post IQ/OQ/PQ test scripts and protocol;
• Statistical Systems validation project (SAS 8.0) – provided guidance in system development and audit
of cGxP documents.
• Served as advisor to project teams and provided direction in the system development, validation
approach, regulatory compliance and best practices for ARISg clinical safety system and Documentum.
• eDMS (Documentum) – phase 2 (publishing and scanning) – provided services in the area of gathering
user requirements, and system validation (review and/or authoring of URS, FRS, Validation Plan,
Validation Protocols and test scripts (IQ, OQ, PQ), Traceability Matrix, Summary Reports, and NDA
submission, for CFR Part 11 project.
QA/Validation Manager for 21CFR11, GAMP Manufacturing/infrastructure (US, Switzerland)
Novartis 10/02- 7/03
• Audited computer systems and directed staff to devise corrective action for compliance to 21CFR Part
11
• Directed and implemented cGXP compliance strategies and Remediation Plan for 21CFR Part 11 for
BPCS
• Directed staff and developed/reviewed validation documentation for both prospective/retrospective
validation (legacy systems). Prepared/reviewed: Quality Plan, URS, FRS, validation protocols, test
scripts/test results, Validation Summary Reports and SOPs
• Served as advisor to project teams and provided direction in the system development and validation
approach and best practices
Project Manager with responsibility for systems engineering, systems development & implementation,
quality process improvement, and off-shore systems development outsourcing at Financial Services Banking
Institution [ISO 9000, IEEE, SEI/CMM, Six Sigma] U.S. Trust 9/01 – 9/02
• Guided the development and implementation of systems engineering and process improvement
practice or the entire organization’s application systems
• Guided the development and implementation of CRM/Siebel project legacy interfaces
• Initiated and provided project management for the off-shore outsourcing of systems development and
support
Quality Manager with responsibility for quality management and process improvement initiatives in clinical
trial and research processes division. These include: (cGCP, cGLP, 21CFR11 ,SEI/CMM, ISO 9000)
Clinical Systems Merck 1/01 – 9/01
• Guided the development and implementation of computer Systems Life Cycle methodology and SOPs
• Audited computer systems and directed staff to devise corrective action for compliance to 21CFR Part
11 for Remote Data Entry (RDE), CDM and other Clinical Data Capture Systems used for
clinical trials
• Directed and implemented cGCP compliance strategies and Remediation Plan
QA/Validation Manager with responsibility for project/quality management and provided direction to project
team members in the validation approach/strategy and directed and managed testing, validation and
compliance best practices for Documentum – SmartSpace (EDMS98) (US, Puerto Rico, Ireland) web-based
project for managing company’s entire documentation (CMM, ISO 9000, MS Solutions Framework, cGMP,
cGCP, GAMP) Manufacturing/Clinical Schering-Plough 1/00 – 12/00
• Directed and implemented process improvement, and development of SOPs
• Implemented change control and management, version control, and document control
• Designed and developed test plans and protocols, test scenarios and test scripts
• Directed requirements/design/coding/testing best practices implementation
• Guided and written requirements specifications, validation plan, test plans/scripts, traceability, SOPs,
3. • Designed, developed, enhanced, and reviewed processes and procedures to meet cGMP compliance
per 21 CFR 820 and 21 CFR 11
• Interacted with all levels of management in numerous functions.
QA/Validation Manager/Validation Specialist - Designed and developed processes and procedures for
project management and quality assurance (QA), management and provided direction to project team
members in the validation approach/strategy and served as a knowledge base for validation and compliance
best practices across SAP™ - R/3, Documentum - Workspace projects, MES. These included: (21 CFR
Part 210, 211, 820, cGxP), (US, Puerto Rico, Ireland) Warner-Lambert(Pfizer) 1996-1999
• Designed, developed, and implemented computer system development lifecycle encompassing the
concept/planning phase through implementation, maintenance phases, and the retirement phase,
standard operating procedures, programming standards, documentation standards
• Directed and implemented cGMP, cGLP compliance, 21CFR Part 11, 21CFR 210, 211, 820, validation
plans and strategy, testing strategies and plans, staff training
• Directed requirements/design/coding/testing best practices implementation
• Directed development of disaster recovery, backup and restore, installation procedures (SOPs)
• Designed, and developed validation plans, test plans and protocols test scenarios and test scripts
• Implemented and managed project plans, schedules, resources, critical path, issue list
• Implemented change control and management, version control, and document control
• Designed/conducted technical reviews and audits
• Responded to auditors’ recommendations from the compliancy perspective
• Interacted with all levels of management in numerous functions
Provided consultation with the implementation of an innovative approach for strategic aligning of information
technology and business objectives. Designed and implemented practice to meet the needs of senior IT
executives - The Office of the CIO (EDS 1995 -1996)
• Instrumental in designing processes and procedures to insure smooth deployment, and coordinated
status meetings for a roll-out of lap-top computers to the EDS staff located World-wide
• ATT - for a new billing system consulted with the design and implementation of change management,
JAD and RAD; improved communication with users 1995 -1996
• Bellcore - advised/assisted with implementation of SEI/CMM/ISO 9000 in several engineering
departments; resulted in systems of better quality. 1993 - 1995
NYNEX Corporation [Verizon] - Science and Technology White Plains, N.Y. 1986 - 1993
Director, Infrastructure Operations and Management (established a brand new division)
Managed staff of 40 people, engaged in Project Management, Computer Systems Administration,
and Total Quality Management. Operating budget of $8M and capital budget of $30M
[ISO9000, IEEE, SEI/CMM, TQM, SDLC, PMO, BPR, JAD, RAD, Harvard PM, Oracle, C/C++,
client/server, SUN, HP, PCs, Ethernet, UNIX, NT, TCP/IP, NFS, FTP]
Bell Communications Research - Piscataway, New Jersey 1984 - 1986
District Manager, Advanced Telecommunications Network Planning
Managed staff of 40 people engaged in design, development and testing large scale applications,
operating budget of $8M, and capital budget of $4M [VAX, Unix, C/CC++, Fortran, Ingress]
EDUCATION
M.B.A. - Stern Business School, New York University, Executive Program, with highest honors
M.S. - Courant Institute, New York University, Computer Science, with honors
B.S. - Brooklyn College, Mathematics, Modern Languages, with honors
ISO 9000 Certified Lead Assessor
PROFESSIONAL ORGANIZATIONS
• IEEE, Computer Society, Sr. Member; Chairperson Software Maintenance Standard; Convener ISO
System Development Life Cycle processes
• Society of Women Engineers, Senior Member
• New York Software Industry Association – Past Member Board of Directors, Chair Export Committee
• American Society for Quality Control (ASQC), Member