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Online Resumes with "CFR Part 11"
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
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
Automation & Control Systems Expert - 20 Years of Experience - Near 06375
QUALIFICATIONS Mr. Sincali has 30+ years experience in project design, programming, & commissioning of distributed automated control systems, electrical energy generation/monitoring/remote distribution control, CNG gas detection systems, pharmaceutical batch processing, paper/pulp mills, water/wastewater treatment SCADA and other advanced process control system applications. Recently, he has successfully implemented many la...
Tags for this Online Resume: Consulting, CT, Ethernet, Pharmaceutical, Automation, Assessments, CFR Part 11, Customer Accounts, Engineering, Hazardous Waste, distributed control systems, expert in PLC, control systems, project engineering
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
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 - 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
