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Online Resumes with "Computer Systems Validation"



Computer System validation Specialist

An IT professional with over 10 years experience as a validation specialist, senior/lead technical writer, documentation manager, analyst, tester, and end-user trainer. IT experience is complimented by solid management and leadership experience gained as a US Army officer.

Tags for this Online Resume: validation, documentation

I am a Chmist and Electronic Licence

Professional Path My experience within the Pharmaceutical and Manufacturing Industry includes over 22 years of experience. This experience includes work in the field of chemistry, process design development and validations, environmental, Quality Control Engineer, Six Sigma, CI4-Plus, equipment installation and validation, analytical investigations of deviation in the laboratory and manufacturing also technical writ...

Ideal Companies: Pharmaceutical, chemistry, electronics.

Business Technology Analyst, Carolina and Guayama Puerto Rico

Luis A. Jiménez Silva Tel. (787) - 653-6759 Home or Mobile 787-662-5229 E-Mail: luisjimenez0710@yahoo.com Skype ID: luis_jimenez_silva111 OBJECTIVE: I am seeking a challenging and opportunity position in Quality System Manage...

Tags for this Online Resume: Office Management, Green Belt, Project Management, LIMS Administrator, Process Supervisor, Quality System Validation

Senior Business and Validation Analyst in technically diverse environments and industries

Ability to troubleshoot and provide proactive, flexible, issue resolution. Demonstrated aptitude to grasp/apply complex ideas and understand quickly. Comprehensive knowledge of SDLC and Validation methodologies.

Tags for this Online Resume: Quality Assurance, SDLC, Regulated, Computer System Validation

Automation & Process Controls Engineer - 20 Years of Experience - Near 27569

Over twenty years equipment and process design, installation and testing of process control and automation systems used across various industries the majority of which are pharmaceutical and food; Fortune 100 & federally regulated corporations. Extensive knowledge of multiple PLC platforms, SCADA programming, MSSQL, InSQL, and RSSQL database designs, implementations & management, InBatch, CDC’s & Wonderware’s Overall Equipm...

Tags for this Online Resume: Automation, Process Controls, Project Manager, I, Pharmaceutical, Biotech, PLCA, SCADA

Quality Assurance Specialist - 14 Years of Experience - Near 39901

To obtain a challenging position that leverages my extensive experience working on a variety of projects, including documentation control, lab equipment and computer systems validation.

Tags for this Online Resume: atlanta, GA, lead QA, quality assurance, trackwise

Featured Profile

Senior Process Validation Lead

Professional with exemplary record in providing Packaging Lines/Process Systems in support of new product presentations and product launches, and improving packaging line and process system efficiencies utilizing Six Sigma Lean Manufacturing concepts. As an astute and organized problem-solver creating solutions and bringing together various groups to have a common consensus and agreement.

Quality Assurance Auditor - 12 years Experience - Pharmaceuticals

Quality Assurance Auditor with proficient skills and experiences in various compliance disciplines. Have a passion to conduct local, international, and global audits, training, and provide guidance services within the following regulatory specialties: â?¢Good Laboratory Practices (GLP) 21 CFR Part 58 â?¢Good Clinical Practices (GCP), VICH GL9, Document 85 â?¢Environmental Protection Agency GLP (EPA-GLP), 40 Code of Federa...

Tags for this Online Resume: Auditor, GLP, GCP, Quality Assurance, QA Manager, QA Auditor

Quality Assurance Specialist - 16 Years of Experience - Near 08742

PROFESSIONAL SUMMARY * Experienced and Senior Software Test Engineer for web and mobile applications, communication systems and IP telephony networks * Highly proficient in creating end to end test strategies including the creation and executing of regression test plans, working with developers to create and execute integration test strategies, and interfacing with customers to test on site and resolve customer specific iss...

Tags for this Online Resume: Integrate, Integration Testing, Test, Troubleshooting, Automation, Documentation, Regression Testing, SDLC, Test Plans, Test Scripts, Quality Assurance

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

Quality Engineer - 10 Years of Experience - Near 00782

PROFESSIONAL SUMMARY QUALIFICATIONS ASQ member, CAPA Expert Certified, CQA, Quality Risk Management - FMEA, Introduction and Internal Auditor for ISO 9001. Knowledge in cGMP Regulations and International Standard (ISO) as 21CFR820, ISO 13485, 21CFR210 & 211, ISO 9001 & ISO 14001. OSHA Rules, Quality Assurance & Control, Manufacturing, Production, Warehouse, Pest Control. Computer skills: Trackwise, SAP, Maximo, LIMS, Visio,...

Tags for this Online Resume: Manufacturing, Documentation, Quality Assurance, CAPA, Audit, Complaints, Investigations, Good Manufacturing Practices, Internal audit, Management, Systems

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