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Online Resumes with "Validation Plans"
Application Support Specialist
Objective: To succeed in a company environment that fosters growth and excellence which provides me job satisfaction and self development and helps me achieve personal as well as organization goals. Aspirations: To be actively involved in a position where I can utilize the skills that I have acquired in my career and to excel in my field through hard work, skills and perseverance so to make an effective contribution to c...
Ideal Companies: Company that promotes team work, values its employees by fostering professional growth and has a positive friendly environment.
Tags for this Online Resume: QA Tester, Application Support, Clinical Systems, Help Desk, Software Tester, Data Manager, EDC, CTMS and CTP, Systems Support, Documentation Specialist
Principal - 20 Years of Experience - Near 06032
I have a strong background in program/project management and business analysis. My experience has included deployment of operational and IT systems, regulatory assurance, operations management, change implementation, customer relations, strategic planning, market forecasting, and budget preparation.
Engineering Program/Project Manager
I am looking for an engineering program or project management position in the field of space, aerospace or renewable energy which can capitalize on the experience I have developed throughout my career.
Ideal Companies: Northrup Grumman, Abbott labs, Philips, Sunpower, Lockheed Martin, Lawrence Livermore National Laboratory, Sandia National Laboratories, Molex
Tags for this Online Resume: Space, aerospace, solar, renewable, mechanical, solidworks, design, project, program, clearance, Project Management, Program Manager, Mechanical design, Spacecraft
Vice President - 20 Years of Experience - Near 92602
I look to utilize my wealth of knowledge and wide breadth of experience to join an organization that is forward thinking, has a good reputation and excellent products to drive the company to new levels of success. Independent of the industry, understanding the KPI’s and defining matrices for these parameters can and will identify areas of opportunity for improvement. My strong analytical background and business acumen has a...
Ideal Companies: An organization that is forward thinking, has a good reputation and excellent products and or services.
Tags for this Online Resume: •Extensive P, •Leader and Team Builder, •Organizational Optimization, •Manufacturing, •Operations Professional, •Sales Professional, •Strategic Planning / Vision, •Post delivery service and support
Lead Clinical data manager- 10 years Experience
Objective: To obtain a challenging career as a professional, utilizing my Clinical research, project management and data management skills with a leading Pharmaceutical Company or CRO
Tags for this Online Resume: NJ, Research, CRO, Clinical data manager, Pharmaceutical , Data Validation plan
Business Analyst - 17 Years of Experience - Near 11725
SUMMARY Business Analyst / Validation Lead / Specialist / IT/QA Compliance Specialist with Pharmaceutical, IT, Manufacturing and Software QA experience: An IT professional with extensive experience in QA/Compliance, Testing, SQA, PM, Validation and Documentation specialties include: * Business Analyst experience consists of specializing in writing business workflow processes and translating them into Business, Functional an...
Tags for this Online Resume: Compliance, Information Technology, Test, Quality, Training, Good Clinical Practices, HP, ISO, Good Laboratory Practices, Manufacturing
Quality Assurance Director - 13 Years of Experience - Near 60453
SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...
Tags for this Online Resume: Compliance, Manufacturing, ISO, Filing, Management, MDR, Process Improvement, Quality, Quality Assurance, Quality Management
Director
SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supp...
Tags for this Online Resume: Extensive experience in CAPA, Extensive experience in IQ/OQ/PQ VAlidation, Extensive experience Quality audit, Extensive experience Supplier Qualification, Extensive experience FDA and ISO Regulatory, Extensive experience Process and Quality improvement, Extensive experience Reducing customer complaint, Scheduling, Chemistry, Good Manufacturing Practices
Quality Assurance Specialist - 12 Years of Experience - Near 03079
SUMMARY OF EXPERIENCE * Software testing specialist with 12+ years of experience working within computer software industries. * Six years directly related experience as software Quality Engineer in a regulated environment and thorough understanding of QSR/MDR/eMDR requirements and FDA expectations related to software validation of ERP, PLM, QMS applications and systems * Strong domain knowledge on Health Care, Pharmacy, Ret...
Tags for this Online Resume: Applications, Database, Extensible Markup Language (XML), IBM, IBM DB2, IBM DB2 Database, Java Programming Language, Management, Microsoft SQL Server, Regression Testing, validation
Mechanical Engineer
Qualifications Profile Highly accomplished engineer, with 19 years of industrial experience supported by 12 years of education in engineering. Extensive experience in product design, simulation, testing, and quality management systems. Experienced in hydraulic and controls components and systems (including hardware and software) design and applications. 14 years of experience using commercial CFD and FEA Software backed-by ...
Tags for this Online Resume: Engineering, Mechanical Engineering, Purchasing, Quality, Research, Audit, Mining, Root Cause Analysis, Swing, Troubleshooting
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 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
