CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "21CFR210"

Clinical Quality Assurance - 16 Years of Experience - Near 30601

A highly efficient, methodical and talented quality assurance analyst who has more than 16 years’ experience in the field of process control, quality and regulatory fields and QA/QC analytical systems. I have considerable experience of developing and implementing effective quality control processes and structures in a manufacturing and corporate environment. Possessing good essentials of safety and quality. Strong customer ...

Tags for this Online Resume: QUALITY ASSURANCE, pharmaceutical, documentation, 21 cfr 210-211, sop, fda, batch record review, audit

Electromechanical Equipment Assembler - 1 Years of Experience

SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.

Tags for this Online Resume: Manufacturing, Packaging, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Audit, Quality Control

Plant Manager - 7 Years of Experience - Near 11705

Tags for this Online Resume: LEAN, 5S, OEE, 21CFR210&211, ISO9001:2008

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

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

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

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,

Department Manager - 20 Years of Experience - Near 00693

Professional validation expert and scientist with up to thirty years of overall experience in the Pharmaceutical Medical Device and Biotechnology Industry. Proficient in manufacturing industry environment including but not limited to facilities utilities solid dosage equipment HVAC water systems chemical plant equipment chemical biotechnology and microbiology instrumentation handling validation (IQ OQ PQ) validation plans c...

Tags for this Online Resume: Quality, Quality Assurance, Project Leader, Project Management, Support, Manufacturing, Test, High Performance Liquid Chromatography (HPLC), Injection Molding, Instrumentation

Quality Engineer

SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.

Tags for this Online Resume: Packaging, Manufacturing, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Quality Control, Training