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Online Resumes with "System validation"
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 Specialist - 7 Years of Experience - Near 08844
Career Summary: Over 9+ years of extensive hands on experience "High potential Software Test Engineer" in diversified fields of the Software Development Life Cycle, specialized in, Quality Assurance Process, Test Automation, Software Testing, Verification, Validation and Reporting across multiple platforms. Seeking position as Validation / Quality Analyst to utilize my expertise and further knowledge. * Excellent experience...
Tags for this Online Resume: Acceptance Testing, Documentation, Pharmaceutical, Test, Test Cases, Test Plan, User Acceptance Testing, Applications, Java Programming Language, Web
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
Data Analyst - 15 Years of Experience - Near 90703
Summary Developer certified in 2015 EPIC Clarity Inpatient adapt at developing, implementing and integrating scalable reports/applications and providing support in the use of business related tools and applications. Key strengths include: * EPIC Clarity Inpatient Certified 2015 * Extensive knowledge of EPIC Inpatient 2015 * Knowledge of EPIC ASAP * Knowledge of Qlikview * Healthcare experience (Claims, quality, pharmacy, do...
Tags for this Online Resume: Crystal Reports, Business Objects, Business Objects Reporting Tool, Quality, Quality Assurance, Applications, Business Requirements, Database, SAP, Training, epic, healthcare, ehr, managed care, qlik, analyst
Life Scientist - 20 Years of Experience - Near 30523
QA Manufacturing Compliance Lead Lead QA Validation Remediation - Comprehensive Product and Process gap assessments of HVAC, Utility Maintenance programs, product Scale-up through commercial validation, packaging and manufacturing process failures, and customer complaints for Prescription, OTC & DEA products. Conduct review of CMO validation change control and QC OOS/OOT reports and write annual Product Review for all produ...
Tags for this Online Resume: Training, Project Management, Distribution, Management, Risk Management, CFR Part 11, Design Specification, pharmaceutical, protocol, Leadership, Staff development, cleaning validation, process validation, computerized systems validation, Program Management, QC testing, Chemist, CAPA, NCR, Customer Complaints, Supplier Quality, commissioning, equipment qualification, equipment purchase, Change control, Auditing, Medical Devices class I, II and III, Pharmaceutical development DOE, Pharmaceutical Clinical Scale-up, Mfg./Pkg. Management, ISO13485, Technical Reporting, FDA site QA contact
Quality Assurance Specialist - 6 Years of Experience - Near 11412
SUMMARY: * Over 6 years of total experience in Client Server and Web Applications, as QA Tester with QA Management skill. * Good experience in defect tracking, defect resolution and defect follow up with SDLC Team. * Extensively experienced in setting and configuring QA Environments. * Experienced in test development, scheduling and execution, test strategy, test project management, SDLC (Software Development Life Cycle). *...
Tags for this Online Resume: Automation, Management, Structured Query Language, Test, Test Cases, Test Plans, Business Analysis, Business Analyst, Documentation, HP QuickTest Professional, sdlc
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
Project Manager - 20 Years of Experience - Near 18020
Summary Over 20 years of business relationship management with a focus on IT project management & operations management. Currently responsible for major pharmaceutical global accounts. Implementing and supporting Medidata full suite of applications. Pragmatic, hands-on global information technology leader with proven experience in the design, deployment and support of strategic enterprise-scale business technology solutions...
Tags for this Online Resume: Planning, Application Server, Budgeting, Citrix, Desk Top Support, Enterprise Requirements Planning, ERP Systems, Gateway, Infrastructure, Infrastructure Project Management, Associate Director project management, Associate Directory Clinicals, Clinical Trials, Medidata
Quality Manager - 15 Years of Experience - Near 02780
Quality professional - 15 years experience in quality systems and validations for medical devices, biologics, and combination products.
Tags for this Online Resume: Risk Analysis, Test, Packaging, Protocol, Manufacturing, Documentation, Management, Systems Documentation, Compliance, Quality systems
Quality Assurance Specialist - 12 Years of Experience - Near 92870
Summary: * Over 18 years of experience in IT with importance on Software QA and AGILE w/ SCRUM. * Experience in Web & Client / Server application, Internet, Intranet, ETL and Databases. Extensive experience with .Net Technologies. * Conversant with all phases of Project Life Cycle including Requirement gathering, Analysis, Design, Development, Implementation, Testing, Software quality standards and configuration management ...
Tags for this Online Resume: Test, Microsoft Windows, Web, Web Services, Web Technologies, Active Server Pages, Business Requirements, Cascading Style Sheets, CSS, Microsoft SQL Server
