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Were you looking for CFR-Part-11 job results?
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Online Resumes with "CFR Part 11"
Business Analyst - 6 Years of Experience - Near 94086
Tags for this Online Resume: Documentation, Web, Business Requirements, Cascading Style Sheets, CFR Part 11, CSS, CSS3, Data Analysis, Data Reporting, HyperText Markup Language
Experienced Director of QA/Validaiton - 15 Years of Experience - Near 27587
Tags for this Online Resume: Validation, Software Validation, GMP, 21CFR, 21CFR PART11, Aseptic Processing,, CAPA, Quality Systems Management, Change Control, Compliance Enhancement, Warning Letter Remediation, Deviation/Exception Management,
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
Microbiologist - 20 Years of Experience - Near 80503
Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbi...
Tags for this Online Resume: Validation, Lab Management, QMS, Compliance, Pharmaceutical, DS, DP, Research and Development, Microbiology, Manufacturing
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
Project Manager - 20 Years of Experience - Near 30655
HIGHLIGHTS OF QUALIFICATIONS * Providing Key Project Management (PMP) as well as hands on experience in the Acquisitions and Mergers of business technology and business practices into new business platforms. This would be the integrating old business legacy systems with new technology or integration into new owner systems and software. Mergers with Airline, Banking and Automotive companies. * Senior management consultant wi...
Tags for this Online Resume: Security, Cellular, Software, Software Development, Strategic Initiatives, ACD, Vignette, Adobe, Automatic Call Distribution, e-Commerce, it jobs, agile, software, sql, Senior Program / Project Manager, M&A Consultant
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
Clinical SAS Programming - 20 Years of Experience - Near 98368
I am a SAS programmer looking for a remote, work from home position I recently moved to a remote area of the Olympic peninsula in the state of Washington, 2 hours west of Seattle. I am looking for a remote, work from home position as a clinical trials SAS programmer. I have experience in applying software engineering and risked-based quality assurance principles to develop a lean, efficient, modular, and well tested ...
Tags for this Online Resume: SAS, 21 CFR Part 11, software engineering, SAS Macros, Statistics, Oncology, manager, CDISC
Programmer Analyst - 8 Years of Experience - Near 22042
PROFESSIONAL SUMMARY * Over 8 years of experience in Information Technology field with strong emphasis in SAS Application Analyst/ Programmer with 3+ years of hands on experience and professional experience in Clinical Trial projects and also worked as Application Analyst in the CROs, Healthcare and Pharmaceutical industries. * Experience in analyzing and coordinating clinical data, generating detail summary reports and dat...
Tags for this Online Resume: Management, Oracle, Oracle 9i, Information Technology, Process Improvements, Coding, Health Care Industry, HyperText Markup Language, Manufacturing, sql, SAS analyst
Business Analyst - 20 Years of Experience - Near 19454
Summary Information Technology Professional with 25+ years of experience as a project manager, business analyst, and developer in the pharmaceutical and financial industries. Background in system implementations and conversions. Exceptional ability to understand business needs and identify opportunities to improve processes using the appropriate technology. Proven track record of delivering high visibility projects on sched...
Tags for this Online Resume: AutoSys, Brio, Ca7, Cobol Programming Language, Documentation, Enterprise Requirements Planning, ERP Systems, File Transfer Protocol, HyperText Markup Language, IBM DB2 Database, agile, sql
Chemical Engineer
PROFILE project management and handling instruments/equipment * Good understanding of various chemical processes (Distillation, Heat Transfer, Fluid Mechanics, Chemical Reaction Kinetics) * Excellent knowledge in ISO Standards, FDA guidelines 21 CFR Part 11, Part 210, Part 211, SOP, cGMP, cGLP, Audit trails, GAP Analysis * Familiar with safety protocols followed in research labs and worked on projects/assignments related to...
Tags for this Online Resume: Statistical Analysis, Audit, Autocad, Autodesk AutoCAD, C Programming Language, CFR Part 11, Corrective Actions, Green Belt, HAZOP, HTTPs
