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Online Resumes with "Computer Systems Validation"
Quality Assurance Specialist - 14 Years of Experience - Near 34685
Summary of Qualifications Over eleven years in a regulated environment including custom built applications, clinical based computer systems, IVRS systems, and data acquisition systems. Seven of those years in an IT management role. Successfully lead teams in promoting quality assurance throughout the software development life cycle (SDLC), both Waterfall and Agile/SCRUM methodologies. Successful in the development and imple...
Tags for this Online Resume: Architect, Project Management, Consulting, Quality Assurance, Software Testing, Systems Engineer, Test, Training, Account Management, sql, agile, html, software, requirements management, requirements gathering, change control, configuration management, project management, audit, management, SDLC, waterfall
Clinical Data Management - 1 Years of Experience - Near 02176
SUMMARY: 4 years of experience in working with both Sponsor and CRO industry focusing on computer systems validation, query management and clinical data management documentation. Worked on creating and handling validation master plan, data management plan, case report forms, change control and data validation specifications. Experience in validation of software's of clinical trial databases, ePRO-electronic patient reported...
Tags for this Online Resume: Documentation, CFR Part 11, Management, Test, Test Scripts, Data Management, Hematology, User Acceptance Testing, Acceptance Testing, Change Control
Quality Engineer - 15 Years of Experience - Near 10312
Summary of Qualifications * Provide validation services for pharmaceutical clients to be compliant with FDA regulations utilizing CSV methodology * Professional with a strong background in validation, quality, information technology, and chemistry domains for pharmaceutical and medical device industry * Proven knowledge of FDA regulatory requirements, including cGxP, GLP, GMP, Sarbanes-Oxley (SOX), 21 CFR 210/211, 21 CFR 58...
Tags for this Online Resume: Services, Data Migration, Legacy, Quality Assurance, Assessments, Audit, Management, Quality Management, Pharmaceutical, Quality, validation, CSV, business analyst
General - 16 Years of Experience - Near 06443
A multi-disciplined, results driven, and goal oriented quality management leader with over twenty years of experience in the regulated pharmaceutical industry. A diverse background that includes all aspects of Quality Assurance (QA) management, Information Technology (IT), and project management. A customer focused and self-motivated team player with a history of working as a leader in team-oriented environments. Success...
Tags for this Online Resume: Auditing, Computer Systems Validation, CAPA, Quality Systems, Research and Development, Pharmaceutical Biotech, Auditing, Quality Management, Computer Systems Validation, CAPA, Supervision, GMP, 21 CFR Part 11, Quality, Quality Assurance, Good Laboratory Practices, Software Quality Assurance, Software Validation
Quality Assurance Director - 15 Years of Experience - Near 06053
To pursue new opportunities related to my experience and knowledge related to Computer Systems Validation, Business Analysis, and Quality Assurance endeavors including management and execution of testing techniques both manual and automated utilizing tools such as HP Quality Center, HP-ALM, Agile Rally and JIRA/JAMA.
Tags for this Online Resume: Management, Test, Test Scripts, Test Cases, Acceptance Testing, Agile Methodologies, Agile methodology, Microsoft, User Acceptance Testing, Documentation
Project Manager - 20 Years of Experience - Near 91302
SUMMARY OF QUALIFICATIONS Accomplished IT Sr. Project Manager and Product Manager with a broad background, over 20 years of experience in all phases of SDLC including the areas of Application Development, Implementation, Deployment, Project Management, Process Improvement, Computer System Validation and other positions of increasing technical responsibility. Knowledge of regulatory requirements and cGMP for computer systems...
Tags for this Online Resume: Database, Database Design, Integrate, Business Requirements, Javascript, BASIC Programming Language, FACETS, Hospital Information Systems, HyperText Markup Language, Legacy, Project Management, Agile, Scrum Master
Electrical Engineer - 18 Years of Experience - Near 00957
QUALIFICATIONS / EXPERIENCE Over Nineteen (19) Years in Pharmaceutical and Biotechnology Industries and Projects Development as service representative, working in engineering design, instrumentation and controllers. Also have been specializing in systems and equipment qualification and GxP validation. Construction: Strong Experience in Commissioning Engineering, FAT (Factory Acceptance Test), SAT (Site Acceptance Test), SIC...
Tags for this Online Resume: Honeywell, Pharmaceutical, Protocol, Assessments, Automation, Distribution, Engineering, Applications, Cadence, Centrifuge
Mechanical Engineer - 1 Years of Experience - Near 48034
Summary: An ambitious engineer with 6 years of educational background over mechanical engineer which includes diverse knowledge over design, thermal engineering, HVAC and fracture mechanics and also experience as Mechanical Engineer Intern at a major bearing manufacturing company. Intermediate knowledge on Validation Engineering and the concepts related to such as IQ, OQ, PQ and other computer system validation deliverables...
Tags for this Online Resume: ANSYS, ASME, Autocad, Autodesk AutoCAD, CAD Tools, CNC, Engineering, Fabrication, HVAC, IBM CATIA, design engineering
Business Analyst
Qualifications Summary * Over Twenty years' technical writing experience in an enterprise delivery setting. Expertise with end-to-end SDLC/ITIL software development process industries I've worked in include: Electric Utilities, Financial Services, Mining, Food and Beverage, Food and Produce Distribution, Health Imaging, Manufacturing, Oil and Gas, Pharmaceutical IT, Retail and Media Relations * Develop both classroom and we...
Tags for this Online Resume: Documentation, Lightweight Directory Access Protocol, Research, Research and Development, Risk Analysis, Script, Technical Documentation, Test, Test Script, Technical Writing
Project Manager - 20 Years of Experience - Near 60124
Skills Summary A Senior Software Professional who has exceptional project management, client relationship and leadership skills with a proven track record of managing multiple projects with multiple stakeholders and multi-disciplinary teams delivering projects on time, on budget and to the client's satisfaction. * A certified PMP having 20+ years of Software Engineering experience that includes: * Project Management and Sta...
Tags for this Online Resume: Project Management, Project Manager, Management, Oncology, ISO, Pharmaceutical, CFR Part 11, Documentation, Change Management, Insurance
Quality Assurance Specialist - 20 Years of Experience
Tags for this Online Resume: Ariba, BMC Software, Cms, CFR Part 11, ISO, LMS, SDLC, Audit, Management, Project Management
