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Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally.
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This individual contributor role is accountable for the implementation of the governance framework to lead Novartis Clinical Document Management (CDM) Reference Model standards, including document taxonomy and metadata guidance, and to drive their adoption across the business and system configuration.
$118,400 - $177,600 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Test Equipment Console layout, ITA Design, Electrical/Mechanical Drafting, 3D Design and Modeling, Configuration Management Practices, Knowledge of Mil/ASME/ISO Standards, machining /manufacturing processes, materials/finishes, thermal calculations/management, Design Review preparation, estimation, and technical presentation package/document development.
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Develop complete construction document sets from Sapphire using PulteGroup tools, processes and standards. full construction document completion. DR Horton - Lennar - Toll Brothers - MI Homes - Beezer Homes.
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This role will be responsible for implementing and managing the site Quality Systems, Training and Document Control programs, identifying, and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to global regulations and BMS policies and procedures.
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Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods. With advanced technical document writing and time management skills, including ability to prioritize and manage expectations.
$47 - $57 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Providing on-time delivery of the proposal document per the instructions of the Bid Manager. Our teams have repeatedly been recognized for outstanding performance by some of the most prestigious organizations in the world including The Boeing Company, Lockheed Martin, NASA & Northrop Grumman.
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Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
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The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing.
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Thorough understanding of pharmaceutical regulations and quality standards, including GMP, GLP, and GDP.Experience with quality management systems, document control, and auditing processes. Establish and maintain standard operating procedures (SOPs) for quality-related processes, including document control, change control, deviation management, and CAPA (Corrective and Preventive Actions) systems.
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The Specialist will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipes validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle.
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The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.
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Title: Validation - Specialist, MSEO Manufacturing Systems Validation. Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs.
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Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR Part 11 electronic records and electronic signatures, and good documentation practices with the Client principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
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Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment. Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation.
$59 - $61 an hourExpandApply NowActive JobUpdated 3 days ago
document job in Morris, NJ
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