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Online Resumes with "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

Engineer - 20 Years of Experience - Near 94565

Henry Martinez has twenty-six years’ experience in the areas of Advanced Control Systems, Instrumentation Specialist, Quality Assurance, Design and Diagnostic set-up for R&D experimentation. During that time he worked on High Profile Projects under the SDI (Strategic Defense Initiative) and the Brilliant Pebbles Programs supported and funded by DARPA (Defense Advanced Research Projects Agency). During the past 15 years, he ...

Tags for this Online Resume: Validation Engineer, Packaging Engineer, Controls Engineer, BMS, Compliance, FDA

Featured Profile

Managing Director - 20 Years of Experience - Near 85326

A top-performing and accomplished professional with 24+ years of experience in executive leadership, logistics control, process optimization, and inventory management. Demonstrated success in administrative planning, maintenance operations management, and safety programs management. Superior ability to prevent problems, employ sound judgment, and develop key decisions. Builds and mentors top-performing teams; thrives in col...

Ideal Companies: any large company

Tags for this Online Resume: Leader, Mentor, Analitical problem solver, charismatic, focussed, team player, professional , proactive

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

Manager - 20 Years of Experience - Near 02343

Tags for this Online Resume: CFR 21 Part 11, Product Data Management , Documentation Management , Change Control , Process , SOP

Featured Profile

Research

To obtain a challenging position within the Pharmaceutical industry or medical devices industry that will allow me to use my experience to play a key role in Clinical Research studies and projects, and/or product development with medical devices.

Tags for this Online Resume: Clinical Pathology, laboratory method development, IQ, OQ, PQ, instrumentation, validation of medical devices, Regulatory, GLP, GCP, IRB, TMF, Project Manager, Documentation Specialist, Scientist, Archives

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

Production Supervisor - 16 Years of Experience - Near 11553

CLARANCE WADE 829 Atom Court, Uniondale, NY 11553 H – (516) 485-4727C – (516) 984-9236 Email –clarancewade@yahoo.com Objective: To be part of a team of dedicated professionals, whose goal is to provide the best service possible for the betterment of the organization. Experience: 8/10-01/15 Bioscrip Home Infusion Pharmacy, Lake Success, NY Shipping Lead- Logistics/Supply Chain Coor...

Tags for this Online Resume: nassau county,ny, suffolk county,ny

Timing Device Assembler, Adjuster, or Calibrator

Tags for this Online Resume: Mechanic, maintenance, packaging, Manufacturing, pharmaceutical, FDA, cGMP, CFR 21 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