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Were you looking for CFR-part-11 job results?
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Online Resumes with "CFR part 11"
EPMO / PMO Leader
Pharmaceutical Information Technology Professional with over 20 years of application design, development, testing, and implementation experience. Areas of expertise include implementing systems and processes to help organizations achieve sustained business performance applied locally and on global program basis. Background includes a unique blend of business acumen, technical expertise, and financial discipline which enable...
Ideal Companies: Medco, Barr, Eisai, Becton Dickinson, Roche
Tags for this Online Resume: IT, Information technology, IS, Information Systems, Technology, Healthcare, PMO, EPMO, Portfolio Management, Project Management
10years bio analytical experience CV
Dear Sir, I believe that my initiative drive and capability for hard work will make me suitable to your organization. I am a person who believes in career satisfaction along with care growth, and it is an organization like yours, which gives utmost priority to employee satisfaction that, will suit my career needs. Here with Iam enclosing my Curriculum vitae for your kind perusal. Hoping to hear positively from your e...
Tags for this Online Resume: Bioanalytical method development, Bioanalytical method Validation, Bioanalytical Subject Analysis in GLP conditions, Experience in LC-MSMS handling, Experience Protocal Review and Reports Review, Experience in 21CFR Part 11
Medical Device / Pharmaceutical Quality and Validation Engineer
I am seeking permanent opportunities as a Medical Device or Pharmaceutical Quality / Process / Validation Engineer. I have enjoyed my experiences in Software and Equipment Validations as well as Engineering Studies and Process Monitoring and Improvement.
Tags for this Online Resume: Validation, Bioprocessing, Specifications, 21 CFR part 11, IQ, OQ, PQ, process monitoring, manufacturing database, Medical Device, Process Improvement
Project Manager - 14 Years of Experience - Near 07901
PMI certified Project Manager • Experience includes projects in insurance and pharmaceutical sectors. • Responsible for full project lifecycle, categorization and management of issues, risks, change and quality management of project deliverables including managing 21 CFR Part 11 Validation and the associated deliverables
Tags for this Online Resume: PMO, SDLC, Clarity, Quality, MS OFFICE, CCCompliance, offshore, Summit,NJ
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 - 10 Years of Experience - Near 08902
Tags for this Online Resume: Quality Assurance, Validation, Documentation, SDLC, eDMS, New Jersey, North Brunswick, 21 CFR Part 11
Computer Hardware Engineer - 20 Years of Experience - Near 19440
Tags for this Online Resume: validation, computer systems, pharmaceutical, laboratory, 21 CFR Part 11
Quality & compliance professional with 24 yrs of experience
With over 24 years of hands on experience in positions of increasing responsibility in Pharmaceutical, Bio and Medical Devices companies. Areas of expertise includes: Quality and compliance (FDA /21 CFR ,809/ICH, GxP’s), CSV (Part 11 and GAMP5) and Serialization (DSCSA), Technical Support (SME for manufacturing and quality areas), Audit in manufacturing and lab areas. Other Quality areas: revision/approval of SOP and Qualif...
Tags for this Online Resume: Quality, Compliance , Validation, Qualification, 21 CFR Part 11, Change control, CSV, 21 CFR 210,211, 809
Validation Consultant-18 years experience in cGMP regulated environment-Dallas, Georgia
Technically accomplished, results oriented professional with 17 years CFR Part 11and GAMP 5, Part 58, Parts 210 & 211, Part 600, 601,610, Part 1270, 1271and Part 820 cGMP regulated environment with 10 years working experience writing, developing and executing validation protocols, managing calibration programs, maintaining and upgrading automated systems in a cGMP environment. Creative Metrologist/Chemist/Biologist and (IQ,...
Quality Engineer - 14 Years of Experience - Near 91016
Over14 years of in-depth experience in the pharmaceutical industry. Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes. 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
Quality Manager - 20 Years of Experience - Near 60096
Experienced Quality Compliance Professional with expertise in managing internal and external audit programs, medical device manufacturing and sterilization process. Excellent knowledge of quality systems and FDA regulations including a strong background in ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR 820 and 510(k) submissions. Experience in statistical process control (SPC) techniques based on ANSI standards. Demonstrate...
Tags for this Online Resume: CAPA, FDA, ISO, Complaints, Auditor
Project Manager - 10 Years of Experience - Near 07901
Ms. Marilynn Goldsmith is a PMI certified Project Manager. Her experience includes projects in integrated oil, insurance, and pharmaceutical sectors. She has been responsible for the project schedule, categorization and management of issues, risks, change and quality management of project deliverables including managing 21 CFR Part 11 Validation and the associated deliverables.
Tags for this Online Resume: SDLC, Offshore Teams, MS Office, Deliverable , Validation, Quality, Team Mgmt, Issue/Risk, Management, Oracle, Database, Documentation, Oracle Database, PWC, Requirements Definition, SEC
