CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "Part 11"

Quality Assurance Specialist

Tags for this Online Resume: Security, Networking, Compliance, Information Security, Microsoft Windows NT, Policies and Procedures, Servers, Configuration Management, Configure, IT Risk and Compliance, CFR 21 Part 11

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

Plant Manager - 15 Years of Experience - Near 72000

Career Summary A challenging position and active involvement in a progressive organization offering the opportunity to fully utilize proven and developing skills. Summary of supportive Qualifications * 15 years of experience in Quality Assurance/Quality Control/Quality System * Excellent skills in Quality processes, Design Concepts (Risk Management) and Problem Solving. * Regulatory compliance (FDA QSR, CMDR, IS013485, MDD....

Tags for this Online Resume: Quality Assurance, Audit, Medical, Compliance, DFMEA, Documentation, manufacturing, ISO13485, Plant Management, Test, Quality Assurance Medical Device

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

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

Clinical Pharmacovigilance/Drug Safety - 10 Years of Experience - Near 19440

Summary Clinical Scientist/Clinical Data Analyst/Clinical Data Management/Project Coordinator/GLP auditor/Research Biologist with over 15 years experience in the pharmaceutical industry. Authored/QC review of protocols, protocol amendments, protocol clarification letters, informed consent forms, risk language, periodic safety reports (PSUR, DSUR, QSR), investigator brochures, medical monitoring plans, clinical SAE narrative...

Tags for this Online Resume: Protocol, Oncology, Audit, Monitoring, Critical Care - Neurology, ICH, Neurology, Quality Assurance, Test, Data Quality