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Online Resumes with "21CFR"
Clinical Regulatory Affairs - 20 Years of Experience - Near 53143
Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...
Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices
Medical Scientist
SUMMARY: * 30 years of experience with diverse range of technical and management experience in the drug, cosmetic and medical device business. * Experienced in leading and managing Six Sigma/Lean process improvement projects. * Use of high level business process mapping to diagnose gaps and find opportunities for process improvement. * Strong background in product formulation and reverse engineering techniques. * Experience...
Tags for this Online Resume: Wound Care, 5S, Kanban, Manufacturing, Medical, Medical Devices, MRP, Pricing, Sourcing, Supply Chain
Business Analyst
SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison be...
Tags for this Online Resume: ACD, Applications, Asset Liability Management, Asset Management, Automatic Call Distribution, Benefits, Business Analysis, Business Analyst, Business Requirements, CFR Part 11
Chemist - 11 Years of Experience - Near 30904
Professional Summary Pharmacist with doctorate degree in analytical chemistry with hands on experience in analytical method development and its validation. Expertise in material chemistry (sol-gel chemistry) and column technology. Have skills and ability to operate wide range of analytical instruments and have basic knowledge of GMP, GLP, 21 CFR Part 210, 211 and validation studies. Currently working in a pharmaceutical ind...
Tags for this Online Resume: Chemistry, Inventory, Pharmaceutical, Regulatory Affairs, Analytical Chemistry, Good Laboratory Practices, Good Manufacturing Practices, High Performance Liquid Chromatography (HPLC), Instrumentation, Its
Project Manager - 20 Years of Experience - Near 08075
Tags for this Online Resume: Pc, Personal Computer, Project Management, Project Manager, Wireless, Microsoft, Purchasing, Accounts Payable, Integrate, Microsoft Office, 21 CFR, GxP, SOX, Infrastructure
Quality Assurance Specialist - 15 Years of Experience
AREAS OF EXPERTISE: * Over 12 years of experience in Computer System Validation (CSV)/Quality Assurance in the Pharmaceutical and Biotech industries including specialization in 21 CFR Part 11 Compliance. * Experience in Computer System Validation including Compliance Assessments, Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), Validation proto...
Tags for this Online Resume: Compliance, Test, Test Cases, Automation, Documentation, Protocol, Risk Assessment, Business Requirements, SAS, Test Plan
Quality Manager - 20 Years of Experience - Near 37129
SUMMARY * Conduct medical device, cosmetic and pharmaceutical excipient and APIs, and supplier certification, evaluation and qualification activities, including on-site and desktop assessments of quality systems, product and process controls develop control plans for monitoring supplier corrective actions for quality, performance and delivery, employing standard industry tools (pFMEA, root cause investigation, lifecycle man...
Tags for this Online Resume: Instrumentation, Diagnostics, ISO, ISO 9001, Management, Document Management, Software, Assessments, Engineering
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
Mechanical Engineer - 19 Years of Experience - Near 45039
SUMMARY * Strong expertise in System Engineering, Mechanical design, FEA & Vibration testing * 19 years of industry experience in product development and project management * Medical device design experience familiar with ISO13485 and FDA 21 CFR 820 Standards * Extensive knowledge of electro-mechanical, fluid mechanics and heat transfer * High-level in multitasking using communication, presentation, and management skills * ...
Tags for this Online Resume: Management, Project Management, System design, Systems Engineer, HVAC, Engineering, MEMS, Research, Instrumentation, Legacy
Quality Assurance Manager- 17 Years of Experience - Near 91790
Highly motivated candidate, fluent in Spanish, with over 17 years of experience working in the medical device industry from feasibility & design to manufacturing and distribution. Interested in broadening my career management opportunities with another medical device manufacturer. Strengths are in leading people, project management, setting up various departments within the organization and helping to establish quality syst...
Tags for this Online Resume: Quality, Medical, Medical Devices, ISO, Management, Complaints, ISO 9001, ISO 13485, 21 CFR
