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Online Resumes with "cfr"
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
Mechanical Engineer - 20 Years of Experience - Near 60565
SUMMARY Over thirty years of combined experiences in engineering design construction and modification in Nuclear and Fossil Fired Commercial Power Generating Stations, Refuse Recovery Facilities, Refinery, Chemical & Pharmaceutical Industries. office as Staff Mechanical Engineer. * Re-calculating size of refurbished Condensate Vertical Turbine Pump to verify if it will work to the new piping route. * Select and size a steam...
Tags for this Online Resume: Documentation, Support, Technical Support, Fabrication, IDS, Layout, Procurement, Pharmaceutical, Scheduling, Audit
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
Quality Manager - 14 Years of Experience - Near 00969
Summary of Qualification Electrical Engineer with broad experience in the Electronic, Electro Mechanic and Pharmaceutical Industries. Green Belt and ASQ-CQE Certified, Black Belt Trained. Strong knowledge on CFR, Aseptic Pharmaceutical Manufacturing Process and cGMP. Managed major document types as Annual Product Quality reports (APQRs), Master Batch Records (MBRs), Standard Operational Procedure (SOPs), Stability Studies a...
Tags for this Online Resume: Quality and Compliance, Audit, Budgeting, GMP, REgulatory, Data Management, Documentation, Fabrication, KPI metrics, Leadership, Management, Change Control
Safety Manager - 13 Years of Experience - Near 20748
Summary of Experience: Experience and certified accomplished safety manager with over 17 years proven track record of successfully managing multi contract, contractor and sub-contractor in engineering construction and infrastructure projects environment through all phases of development. Extensive experience including safety and quality oversight to ensure ISO 9000-2000 standard, safety compliance to 29 CFR 1910 and 1926, 4...
Tags for this Online Resume: ISO, Policies and Procedures, Management, Project Management, Transportation, Compliance, Construction, Documentation, Hazardous Waste, Infrastructure
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 Manager - 17 Years of Experience - Near 60051
SUMMARY OF QUALIFICATIONS * Certified Master Black Belt able to lead and influence people at all levels within a Manufacturing organization. * Proficient in the DMAIC Six Sigma and DMAIC/PDCA Lean Roadmaps, including many different lean and statistical methods such as: Value Stream Mapping, 5S, Visual Management, Quick Changeover, Kaizen Events, Problem Solving, Mistake Proofing, Gap Analysis, Standard Work, Process Map, C&...
Tags for this Online Resume: Software, 5S, Complaints, Documentation, ISO, Product Development, Systems Analysis, Black belt, Kaizen, Management
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
Compliance Manager - 20 Years of Experience - Near 30641
PROFILE Career-driven and results-oriented information-technology professional with a solid portfolio of managing information-technology projects as well as resolving complex technical issues. More than 36 years of progressively responsible experience and measurable accomplishments. Consistently recognized as being able to accelerate, perform, and enhance service. Strategic planner and creative-problem solver, Lead complex ...
Tags for this Online Resume: Compliance, Infrastructure, Quality, SDLC, Assessments, Audit, CFR Part 11, Geographic Information System, HP, Manufacturing, Risk Management, Project Management, SOX
