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Online Resumes with "IQ OQ"



Microbiologist - 20 Years of Experience - Near 07753

Summary I am a Scientist with twenty nine years of professional experience in the pharmaceutical, medical device, clinical and biotech industries. I have written SOPs, CAPA, audit reports, validation master plans, protocols, new product submissions and various other technical documents. I am very familiar with QSR, 21CFR211 and ISO standards: 13485, 14644 part 1 and part 2. I have used the five "whys" and fishbone methods f...

Tags for this Online Resume: Data Entry, Documentation, Root Cause Analysis, Technical Writing, Packaging, ISO, Pharmaceutical, Statistical Analysis, Audit, Management, pharmaceutical, sap

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

Electrical Engineer - 11 Years of Experience - Near 10930

Summary of qualifications Over 30 year's experience, this includes the following: * Instrumentation control system development and implementation. These include Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical instrumentation, Packaging Equipments, Waste treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeration. * Write and execute test scripts Installation Qualification, Operatio...

Tags for this Online Resume: ISO, Instrumentation, Medical, Quality, Quality Assurance, Quality Control, Clean Room, Control Systems, Fabrication, Surgery

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

In Between - 15 Years of Experience - Near 27572

QUALIFICATION SUMMARY Thirty-five years of pharmaceutical/biotech industry biotech with management experience. Able to adapt to rapidly changing business situations and move forward with change while using strong communication skills to facilitate a high level of collaboration among peers and co-workers. Broad background of experience and expertise in the following areas: * Quality Control/Quality Assurance * Team Developme...

Tags for this Online Resume: Training, Corrective Actions, Data Processing, Good Manufacturing Practices, Manufacturing, Quality Assurance, Test, Data Entry, Document Management, Filing

Quality Coordinator

SUMMARY Quality Assurance Manager with expertise in pharmaceutical and chemical, quality control and quality assurance areas. Managing and coordinating quality assurance functions of pharmaceutical and chemical industry from inception to completion while communicating horizontally and vertically in a highly regulated FDA/EU environment. Possess a background in both Fortune 500, entrepreneurial and start-up environments. Exp...

Tags for this Online Resume: Complaints, Quality, Quality Assurance, Quality Control, Compliance, Test, Audit, Corrective Actions, DSC, High Performance Liquid Chromatography (HPLC), rn

Quality Manager - 20 Years of Experience - Near 37064

Manager - Accountable for all aspects of ISO 9001:2008 quality management system and quality control. * Lead a staff of 8 quality professionals provided unprecedented level of service to both internal and external customers. * Developed formal validation and design procedures for medical device components compliant to cGMP. * Led all CAPA (RCCA) efforts. Enhanced successful closure by 70% and strengthened root-causes and tr...

Tags for this Online Resume: Science, Acceptance Testing, Protocol, Quality, Quality Assurance, Test, Manufacturing, Corrective Actions

Mechanical Engineer - 1 Years of Experience - Near 48034

Summary: An ambitious engineer with 6 years of educational background over mechanical engineer which includes diverse knowledge over design, thermal engineering, HVAC and fracture mechanics and also experience as Mechanical Engineer Intern at a major bearing manufacturing company. Intermediate knowledge on Validation Engineering and the concepts related to such as IQ, OQ, PQ and other computer system validation deliverables...

Tags for this Online Resume: ANSYS, ASME, Autocad, Autodesk AutoCAD, CAD Tools, CNC, Engineering, Fabrication, HVAC, IBM CATIA, design engineering

Industrial Engineer - 15 Years of Experience - Near 06422

SUMMARY An analytical, results-driven quality management professional with extensive experience leading quality in Medical Devices, Biologics, Combination products, Pharmaceuticals, 510K and 503B Human drug compounding. Hands-on experience in new product development, design for six sigma, validations (IQ, OQ and PQ), risk management, complaints/post market surveillance, CAPA, auditing, supplier management, cGMP/GLP, as well...

Tags for this Online Resume: Quality Assurance, R&R Report Writer, Test, Quality, Assessments, Complaints, Troubleshooting, ISO, Medical, Medical Devices, Quality ASssurance, Medical Device, ISO, 503B, Complaints, Design Control, Quality,

Process Engineer - 15 Years of Experience - Near 55376

To benefit an organization that can use a knowledgeable Six-Sigma Black Belt Quality Manager with a proven ability to continuously improve processes/customer satisfaction and supplier development while building a strong project team, and strengthen customer relation using various Six-Sigma/Project Management tools and methodologies. Responsibilities: ISO 13485, 14971 Managing/Directing quality staff. Supervising/ Mentoring ...

Tags for this Online Resume: Audit, Data Analysis, CMM (Capability Maturity Model), Management, Product Development, Reliability, Stents, Heat Treating, Plastics, Msa (Accounting Pkg)

validation/quality/manufacturing engineer

PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...

Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing

PROJECT MANAGER

Career Summary * Over a decade of experience with medical device manufacturing, inclusive of the following: * Project Management, specifically New Product Development * Design Engineering and Control * Manufacturing Engineering and Six Sigma Manufacturing * Process Development and Statistical Process Control * Quality Management, Testing, and IQ/OQ/PQ Validation * Regulatory Compliance and GMP (FDA Class I, II, and III devi...

Tags for this Online Resume: Billing, Compliance, Documentation, Engineering, Management, Medical, Medical Devices, Process Control, Program Manager, Quality, PROJECT MANAGER, PROJECT ENGINEER, MANUFACTURING ENGINEER, MEDICAL DEVICE MANUFACTURING, REGULATORY COMPLIANCE, DESIGN & DOCUMENTATION, OPERATION MANAGEMENT, SALES & MARKETING