Highlights;1. Developed testing strategies for 1st cloud based Watson healthcare infrastructure at IBM healthcare. Performing process improvements on processes related to global software defect management, validation, documentation, change management and risk management.2. As part of a quality improvement program, created a global supplier management system that included assessment, questionnaires related to telephony, service, GxP COTS and data centers of 589 IT suppliers for Abbott Laboratories as part of acquisition of Alere Inc.3. Managed more than 13 global IT project implementations for Philips health care in 2 years that involved implementation of systems such as IBM WebSphere, MDM Informatica, Cast Iron, Valgenesis etc4. Led 8 must have projects for Mylan pharmaceuticals for 2014 affecting 44 sites globally with over 37 stakeholders. the projects budget was over 8 million5. Remediated JDE Edwards system for suppliers and materials management for Terumo cardiovascular >600 programs6. Evaluated documentation for over 80 lab systems for Norvatis7. Implemented an off shore delivery center with TATA consulting for 42 engineers in Noida, India, Switzerland, Germany and Australia for VISIONAIRE® product a 3D orthopedic bone implant system8. Developed a SAAS and Software as a device quality system for assimilation of 1st medical device as a software for LifeMod integration with Smith & Nephew9. Audited over 17 companies globally with corrective actions in the last 2 years with ClinAudits & SCVS10. Selected as SME for data integrity assessment for laboratory systems for FDA issued consent decree 11. Resolved a problems -saved an organization 7 million dollars loss per year as part of a Black Belt certification project for a hospital in Florida.Other projects;- Unity Biotechnology - QMS implementation- Emergent Biosolutions - Empower, Veeva and Data integrity - 6 sites- Guebert - StarLIMS implementation - PRA Health Sciences - IT Quality Corporate

As part of a team involved in the implementation of Watson Health Platform

• Managed 589 Suppliers and Service Providers utilized by Global IT organization • Generated Supplier Assessment and Qualification records, to document how suppliers met the service requirements of Global IT organization and met requirements.• Performed Supplier Risk Assessment • Generated rationale for retrospective approval as necessary

Led system qualification efforts and was the primary client contact for coordinating work, reporting status, resolving issues, and addressing change requests as applicable. Reviewed deliverables ensuring the accuracy, completeness and compliance of validation documents by reviewing the validation packages. This included providing oversight and assurance that validation documentation met FDA regulatory, cGMP/GMP, and internal quality requirements.Actively participated in the Validation Life Cycle of regulated projects by developing and driving validation deliverables in accordance with defined procedures, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management; and worked closely with cross-functional project teams across Healthcare in appropriate verification and validation testing requirements.Supported Quality & Regulatory Validation Operations group in following the established process and procedures for Validation in Healthcare business.Provided guidance/feedback to business stakeholders in Validation compliance as per the applicable regulatory requirements and Philips Healthcare policies and procedures.Worked cross-functionally with IT, and the supporting businesses to implement improvements to computer systems; while adhering to the regulatory validation requirements, company QMS procedures, and industry best practices.Served as an active participant as CSV Subject Matter Expert in internal and regulatory inspections.Worked independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.

As part Laboratory In Control Project, led and performed system assessments for 17 types of laboratory systems. Identified gaps in documentation and recommended corrective actions to bring them into compliance.

Led 8 projects with global implications in implementing various IT solutions. The projects affected over 44 sites globally.

Led an initiative to develop, integrate, educate the organization in systems compliance while developing quality system for the entire organization. Participated in the identification and implementation of Master Control to organization.

SAP -JD Edwards -ERP Remediation and Validation

Provided global multiple project leadership and created an integrated Global Quality Software System that include leading the remediation of legacy and validation existing software. Provided expertise and technical guidance regarding all aspects of software applications for medical products, manufacturing systems, and software validation. Guided all global locations in the validation of manufacturing systems, web based applications, and medical device software. Interacted with all levels of management to communicated software validation requirements and project schedules. Performed international audits of software applications and systems, developed software validation specifications, software validation master plans and established controls for the software life-cycle. Represented the software validation team in internal and external audits. Led team in FDA submission activities and validation of VISIONAIRE a 3D Patient Matching Technology in Sidney, India and Switzerland

As a member of the Site Software Quality Team, Global Software Quality Representative and QA supporting the Legacy Software Remediation Team, Provided QA support for software changes, validation strategy and remediation efforts for computer systems and manufacturing equipment for the Spencer site. Team Members included 10 Software Validation Engineers, 1 Equipment Tech and 1 Co-Op.Sr. Quality Engineer MES (Manufacturing Execution System) -CamstarProvide eMfg QA Support for implementation of MES to 23 manufacturing lines at Spencer facility starting with the Interject line. Improved quality processes by integrating MES into Spencer with the Global Quality System.

Production Systems Remediation and Cleaning Validation for site

Led a team of 4 in the remediation of over 114 legacy manufacturing equipment and revalidation initiative for entire facility. Participated in the development and execution of cleaning validation. Approved and reviewed all high risk equipment validation protocols and cleaning validation documents

Performed various Computer Systems Validation for a number of companies located in SC, CA and MD

As part of a team addressed FDA's 483 observations, completed a mega interdepartmental project to implement corrective actions to the FDA observations. Implemented laboratory automation system that included the Waters Lab informatics (Nugenesis), lab software qualification and paperless initiative for lab data. Led an aggressive project to transfer analytical test methods from India and re-validating them in the US while addressing DEA requirements.

Proficient in USP-NF Product Testing Methodologies for Solid and Liquid Dosages. Led a project to upgrade analytical methods for a company to claim "tested per USP". Developed analytical methods for EPA, NPDES (Testing Methodologies for National Pollutants). Hired over 20 new chemists in response to added laboratory load Completed the purchase and qualification of Stability Chambers, GC's, LC's and misc Lab equipments.

Pursued Masters in Science Engineering Technology Management.

As QA/QC Supervisor, led a team of 40 analysts in the analysis and release of solid dosage products at Cardinal Health Products (also known as Adams Laboratories). Responsibilities included: Managing the release and testing of raw materials and finished products. Initiated and investigated and wrote Non-Conformances and acted as final reviewer of analytical data, trained new users in the use of the client server system, fixed and maintained all laboratory systems when possible and or scheduled vendor repairs. Validated HPLC's as required.