CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "21 CFR part 11"

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

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

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

Biostatatician - 18 Years of Experience - Near 07059

Experienced with IND/NDA submissions, and knowledgeable in regulatory guidelines (ICH), 21 CFR Part11 and Good Clinical Practice (GCP). * Highly experienced in clinical protocol development, experimental design, sample-size and power calculation, randomization, and study analysis planning (SAP). * Proficient in SAS/Base, SAS/Stat, SAS/Graph, SAS/Macro and SAS/ODS. * Skillful in data validation data manipulation, graph, tabl...

Tags for this Online Resume: Health Care Industry, clinical, protocol, sas, pharmaceutical, sap, ich, gcp, trial, phase, oncology

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

Quality Professional

Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...

Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis

Engineering Manager - 20 Years of Experience - Near 94552

Tags for this Online Resume: Associate in Commercial Underwriting, Technical Writing, Integrate, Engineering, Instrumentation, Programming, Support, Weapons, Assessments, Automation, pharmaceuticals, validation, engineering, CSV, 21 cfr part 11, risk, protocols, GMP, facilities, medical device, FDA, ICH, EU, GAMP, change control, validation master plan, facilities master plan, aseptic processing, packaging, packaging line, WFI, clean steam, PW, SIP, CIP, process validation, critical process paramters, capital project, project management, electronic record, strategy, planning, leadership, solid dose, standards

Quality Coordinator - 6 Years of Experience - Near 60504

PROFESSIONAL SUMMARY: * Total of 9.5 years of experience in Health Care industry. 6 years' experience in Clinical Data Management. * Worked as a Clinical Data Coordinator in Quintiles Technologies from Feb 2011 to Aug 2014. * Worked as a Clinical Data analyst in PAREXEL International from Aug 2008 to Feb 2011. * Also, I have 3.5 years of experiences in Medical Microbiology field in health care sector I started my career as ...

Tags for this Online Resume: Data Management, Health Care Industry, Management, Microbiology, physical therapist

Laboratory Manager - 18 Years of Experience - Near 28037

Qualifications Summary Laboratory Manager with extensive experience in regulated pharmaceutical manufacturing and research and development with more than 10 years of management experience. Thorough understanding of regulated Laboratory environments including but not limited to GMP, GLP, GDP and 21 CFR Part 11. Quick learner with proven track record of driving success. Skilled at navigating FDA and vendor audits. Implemented...

Tags for this Online Resume: Project Leader, Project Management, Budgetary, Drafting, High Performance Liquid Chromatography (HPLC), Management, Planning, Rational, White Papers, clinical, phase, trial, gcp, protocol, pharmaceutical, Quality, LC/MS

Life Scientist - 20 Years of Experience - Near 02642

SUMMARY IT/QA PROFESSIONAL Biotech - Pharmaceutical - Medical Device - Life Sciences Highly skilled consultant and Project Manager with diversified domestic and international experience and a background that incorporates strong technical orientation with business skills. Hold proven record of success in product development, process improvement, cGMP compliance, validation and quality control. Examples: * Software Implementa...

Tags for this Online Resume: Software, Compliance, HVAC, Management, Support, Assessments, Automation, Integrate, Manufacturing, Millenium (Sw-Fin/Admin), gcp, pharmaceutical, sas, protocol, clinical

Quality Assurance Specialist - 13 Years of Experience - Near 08540

Professional Summary More than 14 years of experience in Pharmaceutical and Life Sciences Industry with key focus in Business Requirements Analysis Data Analysis and Management Software Application Testing Document Management Change Control and Release Management FDA Compliance Verification and Validation Quality Assurance Processes and Methodologies Developing Testing Strategies and Test Plans Test Scenarios and executing ...

Tags for this Online Resume: Test Scripts, Test, Management, Test Cases, Structured Query Language, Audit, CFR Part 11, Test Plan, Application Server, Documentation, validation of protocols

Quality Assurance Specialist - 6 Years of Experience - Near 75093

SUMMARY * Experienced with Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). * Experienced in Agile and Waterfall environments. * Experienced in using HP interactive products like -HP Quality Center (ALM/QC) and JIRA. * Good exposure to Web technologies like HTML, XML and JavaScript. * Experience in SQL queries and Joins (Inner/Outer) to validate data. * Experience in IVR/IWRS Testing. * Experie...

Tags for this Online Resume: Management, Oracle, Regression Testing, System Testing, Test, Software, JIRA, Microsoft, Microsoft ASP.Net, Microsoft SQL Server, sql, java, javascript, agile, html, software