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Online Resumes with "Cfr Part 820"
Quality Engineer-10 years experience-ISO13485-21 CFR Part 820
Tags for this Online Resume: Deviations, QMS Documentation, Customer Complaints, Quality Plans, CAPA, Risk Assessment
Chemist
I have 14 years of experience in pharmaceutical industries. Results oriented individual with a track record of instituting and maintaining high levels of Quality Assurance and leadership. Iām seeking additional opportunities for professional development in consulting, validation, compliance or technical areas. Strong analytical and planning skills. Six Sigma Black Belt trained. Knowledge in FDA, cGMP, GLP, 21 CFR - Part 820...
Ideal Companies: Pharmaceuticals or food industries
Tags for this Online Resume: qa, validation, lims, qc
Senior staff scientist / Program Manager
Manage / implement a product stability program under current regulations; manage implementation of FDA requirements post 510(k) clearance
Ideal Companies: medical device companies; adjunct college professor; education manager within a company
Tags for this Online Resume: Product Quality Support, Product stability , medical device software validation, adjunct professor_biology
Engineer - 20 Years of Experience - Near 48237
Experienced Quality Engineer in the Medical device manufacturing. Maintaining QS,FDA and ISO 13485 regulated industry. Hands on experience on inspection and testing.
Tags for this Online Resume: CQE, Coordinate Measuring Machine, ISO 13485, 21 CFR Part 820, CAPA, Complaints, Automation, Automotive, Consulting, Dialysis, Engineering, Internal Auditor, ISO, ISO 9000, Automation, Automotive, Consulting, Dialysis, Engineering, Internal Auditor, ISO, ISO 9000
Chemist - 20 Years of Experience - Near 33411
I am a Quality Assurance professional with over thirty years of experience in Quality Assurance in the Pharmaceutical, Biotechnology and Medical Device Industry.
Ideal Companies: Medical Device or Pharmaceutical Companies
Tags for this Online Resume: Failure Investigation, Corrective Action, Preventive Action, Training, cGMP's, Florida, Auditing, pharmaceutical
Quality Manager - 15 Years of Experience - Near 55044
Tags for this Online Resume: Six Sigma Black Belt, Lean Manufacturing, Continuous Improvement, AS9100 and AS9102, FDA 21 CFR Part 820
Quality Engineer - 14 Years of Experience - Near 91016
ļ Over14 years of in-depth experience in the pharmaceutical industry. ļ Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes. ļ Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches...
Tags for this Online Resume: QUALITY, SUPERVISOR, MANUFACTURING, PHARMACEUTICAL , HARD WORKER, RESPONSIBLE, SQL, LIMS, Distribution, Documentation
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 - 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
Not Listed - 20 Years of Experience - Near 07936
SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...
Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist
Risk Management - 19 Years of Experience - Near 01845
FAMILIARITY WITH: ISO 1009, ISO 10993, ISO 13485, ISO 14969, ISO 14971, ISO 24971, 21 CFR Part 11, 21 CFR Part 820, IEC 62355-1, and HIPPA.
Tags for this Online Resume: Test, Test Plans, Quality, Unix, C++ Programming Language, C/C++ Programming Languages, Java Programming Language, Management, Quality Assurance, Software
Business Analyst
SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison be...
Tags for this Online Resume: ACD, Applications, Asset Liability Management, Asset Management, Automatic Call Distribution, Benefits, Business Analysis, Business Analyst, Business Requirements, CFR Part 11
