Experience

Aegle HCS

• Hospitals and Health Care
• 1 - 100 Employee

• Owner

  • Aug 2017 - Present

  Increase revenues for the company and oversee the business growth with RCM Clients in the US, and develop strategy which will help setup onshore support to our RCM customers. Help hospital, clinics to increase their revenue with the innovative idea and solution. Increase revenues for the company and oversee the business growth with RCM Clients in the US, and develop strategy which will help setup onshore support to our RCM customers. Help hospital, clinics to increase their revenue with the innovative idea and solution.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Lead

  • Aug 2011 - May 2019

  - Hosted audits by sponsors and regulatory inspectors - Ensured compliance with applicable regulations and for GMP operations related to manufacturing, testing, packaging, and distribution of investigational drug product. -Lead comprehensive GMP Quality audits of current and new vendors. -Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines; - Authored, maintained, and revised departmental Standard Operating Procedures (SOPs), forms, and templates; - Coordinated, conducted, and tracked company-wide regulatory training (ICH/GCP and medical device); - Developed training materials and applicable tests and guides; and worked with outside clients/sponsors. - Responsible for managing multiple large and mid-size high visibility projects simultaneously as the lead Validation resource, which involved providing SDLC guidance throughout the lifecycle process and for change controls after post Production. - Managed validation project deliverable, timelines, work streams, and resources from analysis through deployment. - Led validation efforts for Data Migration of Legacy Systems from Planning phase through release of data for Production use. Authored/reviewed Data Migration Plan, Mapping Documents, Data Migration Test Scripts and Data Migration Summary reports. - Assisted in developing the project plan to document the validation deliverables and to ensure the quality gates are met between lifecycle phases. - Acted as the interface in communication between Technical, Business and Quality resources to ensure that the system development, implementation complies with company defined and regulatory standards and perform quality management.



Corelab Partners Inc

• Princeton, New Jersey, United States

• Validation Lead

  • Aug 2006 - Jun 2011

  As primary lead for validation activities, directed system life-cycle validation and management of enterprise-wide core systems and processes that support the daily operations of radiology lab—these include supporting systems that acquire, support Quality Control functions, blinding of participant information and analysis of radio-graphic images supporting clinical research As primary lead for validation activities, directed system life-cycle validation and management of enterprise-wide core systems and processes that support the daily operations of radiology lab—these include supporting systems that acquire, support Quality Control functions, blinding of participant information and analysis of radio-graphic images supporting clinical research



Schering-Plough Research Institute

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Senior Software Tester

  • Sep 2005 - Jul 2006

  Involved in Testing of Global Pharmacovigilance – Corporate Adverse Event Reporting and Evaluation System (GPV-CARES) for clinical trials and marketed drugs. Responsibilities:  Created functional scripts to test the functionality, security and data integrity within the system.  Acted as expert resource in testing team of 20 testers; responsible for final review of 250 scripts before scripts were approved for formal execution.  Acted as point person on operational support and gatekeeper of GPV-CARES system functionality.  Revised functional scripts after error resolution determination during dry run execution; mapped to Requirements specification to ensure full traceability to revised scripts.  Performed 50% of total formal test execution.  Reviewed requirement specifications for completeness, testability and adherence to SOPs  Addressed and resolved System and Requirement issues  Interacted with development and project management teams, initiated defect review meetings  Extensive involvement in training, technical support and trouble shooting system issues with other testers, Validation specialists and Users.



Danucom Corp

• United States
• Software Development

• Senior Quality Engineer

  • Jul 2002 - Sep 2005

  For client Veritas Medicine (Cambridge, MA). Veritas Medicine is an online health resource, a comprehensive clinical trials database that allows patients to be matched to clinical trials based on information submitted confidentially.  Performed duties as a validation specialist in reviewing all relevant compliance documents (Validation Plan, User and functional requirements specifications, SOPs) to enable testing the Veritas website and database.  Authored technical Validation documents for in-house and external clients including Design Specifications, Unit, System Integration, and Acceptance Test Scripts, and Traceability Matrices to track requirements.  Coordinated system testing and executed system and UA Test Scripts.  Performed operational support of clinical database, participated in enhancements to production change control.



Schering-Plough Research Institute

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Quality Assurance Consultant

  • Apr 2002 - Jun 2002

  Windows 2000 Professional Platform Core Image  Wrote Test cases, scripts, execution logs, and defect reports, following Microsoft® Solutions Framework (MSF) suite of models, principles, and documents for building and deploying distributed enterprise systems to verify compatibility and usability of the Core Image and the associated applications.  Performed Configuration, Sequence, Compatibility, and Performance testing to verify that proper operation of hardware, operating system software, and operational documentation is complete.  Executed test scripts as per testing documentation and followed detailed validation oriented documentation standards.



Telcordia Technologies

• United States
• Telecommunications
• 400 - 500 Employee

• Software Quality Engineer

  • Oct 1998 - Aug 2001

  Responsible for Requirements Analysis, Design, Quality Control, estimating and planning aspects of Telcordia Switch Element Activation Manager. Was responsible for Quality Assurance/Control for a C++, Java, NT, HP-UX, Oracle and CORBA based Client-Server application, utilizing Distributed Computing Environment, to manage subscribers’ service information on telecommunication exchanges. Main responsibilities include:  Taking business critical and major enhancements from Analysis and Design and Testing, involving detailed requirements decomposition, authoring and championing STTS documents using CMM Level 5 approved processes, procedures, methodologies, techniques and standards, and, their subsequent realization of all related deliverables, especially the quality assurance. Examples include:  Writing critical STTS documents to support the front-end and the back-end  Took charge of SQA on the front-end GUI, both usability and functional testing  Made necessary changes in regression scripts with each enhancement to the system.  Took charge of several regression test cases using MYNAH Regression Testing Tool.  Administrating security for the GUI  Served as a primary contact for other solution members of Telcordia Technologies.  Also responsible for Customer Acceptance Testing Plan (CATP) used to certify the product at the customer site.  Requirements:  Took part in usability requirements for the front-end GUI.  Took critical part during the design of flowthrough system.  Troubleshooting business critical parts of the application, requiring quick turn around of incidents without jeopardizing quality.