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Online Resumes with "CAPA "
Engineer - 20 Years of Experience - Near 02720
Tags for this Online Resume: CAPA, process validation, process development, root cause investigation, ISO 13485, QSR / FDA CFR Part 820
Quality Assurance Director - 4 Years of Experience - Near 08736
Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...
Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate
Quality Engineer
Summary: John has been an ASQ-certified Quality Engineer and ASQ-certified Quality Auditor and a Philips-Global-certified Lead Auditor with a strong experience within medical device, pharmaceutical and contract packaging companies, while following FDA drug Good Manufacturing Practices, FDA medical device Quality System Regulation, ISO 9001 and ISO 13485 environments. He has a solid understanding with QSR supplier control sy...
Tags for this Online Resume: Compliance, Quality Assurance, Support, Technical Support, Test, Corrective Actions, Medical, Medical Devices, ISO, Audit
Quality Manager - 12 Years of Experience - Near 19701
Summary Accomplished Quality Assurance Professional with extensive experience in developing, implementing, and successfully sustaining quality management systems in various manufacturing companies including virtual pharmaceutical facilities, while assuring local and international regulatory compliance. Proven expertise in developing quality improvement plans, supplier management programs, auditing, streamlining procedures a...
Tags for this Online Resume: Management, Process Improvement, Risk Management, Disaster Recovery, Kaizen, Manufacturing, 3PL, Audit, Packaging, Quality Management
Quality Assurance Specialist - 12 Years of Experience - Near 33134
Results-driven database engineer with over 15 years of experience with Fortune 50 medical device companies and Safety Surveillance and Regulatory Agencies worldwide. Strong skills in preparation of quality system requirements, development, and compliance under strict deadlines. Extensive application development with data integrity and auditing. Skilled reporter in analytics with reputation of setting industry standards. ( ...
Tags for this Online Resume: MDR, Data Architect, Reporting, Failure Analysis, CAPA, Medical Devices, Apache Hadoop, Application Development, Audit, Business Intelligence, SAS, SQL OBIEE
Clinical Quality Assurance
SUMMARY A results-oriented and performance-driven operation leader with extensive experience in the medical device and in-vitro diagnostics and treatments in healthcare industries. Consistently delivers improvements in customer satisfaction, quality, and product performance. Possesses well-developed analytical skills and an ability to synthesize data into meaningful information for the organization. Close attention to detai...
Tags for this Online Resume: Manufacturing, Product Development, Hematology, Quality, Quality Assurance, Quality Control, Support, Technical Support, Test, Corrective Actions
Clinical Quality Assurance - 20 Years of Experience - Near 02804
Tags for this Online Resume: Quality Assurance, Consulting, Compliance, Audits, Document Review, Validation, Batch Disposition, CAPA
Quality Engineer - 1 Years of Experience - Near 94539
Summary Masters in Industrial Engineering with proficiency in Lean six sigma, Process Engineering, Statistical data analysis, Time study analysis, Quality Improvement, and logistics and also have around 2 years of experience in quality engineering with a good knowledge of PDCA, APQP, PPAP, FMEA, CAPA, 8D, TQM, Auto CAD, Microsoft Excel and VBA Programming. Strong penchant towards analytic and problem solving skills. Good co...
Tags for this Online Resume: Manufacturing, Problem Solving, Quality Assurance, Root Cause Analysis, 5S, APQP, CAD Tools, Data Analysis, Engineering, Industrial Engineering
Biologist - 3 Years of Experience
Project summary: Apomimetic peptides are novel drug candidates to treat atherosclerosis because of their ability to mimic the native apolipoprotein functions. Human PON1 (Paraoxonase1) activity was known to increase in presence of apomimetic peptide-lipid complexes. This increase in PON1 activity may be attributed to 'alterations' in secondary structural components (possibly tertiary structure) of PON1. The project includes...
Tags for this Online Resume: cGMP, Electrophoresis, ELISA, Protein purification, Chromatography, Filtration and diafiltration, Procurement, Chromatography systems, Formulation, English Language, Validations, CIP and SIP, Nanofiltration, UV spectroscopy, GDP, CAPA, Incidents and Deviations
Engineer - 19 Years of Experience - Near 33184
Tags for this Online Resume: Audit, Product Development, Risk Analysis, Software, Software Development, Support, Technical Support, Test, Documentation, Quality, Validation, Verification, Human FActor, CAPA, ISO 14971:2012, GMP, 21CFR Part 11, SPC, Post Launch Risk Assesment
Quality Manager - 20 Years of Experience - Near 30152
Known as a Quality and Operations Leader for improving business results and promoting the quality approach to doing business by example. I believe everyone has a customer and a supplier regardless of their function in the organization. * Led the effort at both Ampac and Printpack in developing and implementing a corporate-wide management system based on the ISO 9001 ISO 13485 ISO 14971 ISO 11607 as well as other FDA EU and ...
Tags for this Online Resume: Pharmaceutical, Manufacturing, Management, Process Improvement, ISO 9001, Product Development, Purchasing, Continuous Improvement, Quality Assurance, ISO 13485, Lean Methods, Six-Sigma, Corrective Action, CAPA, Root Cause Analysis, Package Manufacturing, Quality Management, Training Management
Life Scientist - 19 Years of Experience - Near 07652
& Major Accomplishments
Tags for this Online Resume: ISO, Documentation, Compliance, Training, Lean Six Sigma, CAPA, Auditing, Budgeting, Change Control, Complaints, Management, gcp, pharmaceutical, sap, ich
