Consulting

Consulting

Optimize Your Supply Chain with our OT/IT Quality Advisers

As your Pharma, Bio or Med Device company evolves and repositions, let Global OT/IT Quality Services Inc. assist in developing your operations and information technology infrastructure. We serve as a strategy adviser for Life Science companies as they seek to improve their connected supply chain and optimize their manufacturing operations With an ever-changing landscape, it is common for companies to continue to acquire, divest, and merge manufacturing. Whether you have recently acquired a company or are outsourcing your manufacturing, these alterations directly impact and challenge the supply chain and the ability to move products quickly to market.


Our experience with plant expansion, manufacturing and packaging line startups as well as full site decommissioning makes us an ideal partner to support your ever changing needs.

A Sample of Global OT/IT Quality Services Resource Profiles

Manufacturing IT Architect/Project Manager - Dynamic, results oriented IT and automation executive with, over 30 years of experience in cGMP manufacturing. Successfully implemented the first dock to stock Pharma MES in North America leading the way to many more successful implementations throughout the world. Developed global and local short and long-term strategies for manufacturing optimization through process re-engineering and automation. Created and led a global manufacturing IT and automation organization for a major Pharma company.


Manufacturing IT and Supply Chain Consultant - Results driven IT executive with 28 years of experience in pharmaceutical manufacturing systems. Successfully implemented manufacturing shop floor and QC systems including automated warehousing, in-process testing, LIMS, PAT and MVDA systems. Very experienced in developing user requirements, project scope and detailed project management needs and managing large global projects involving diverse teams.


Quality IT Project Manager - Results oriented executive whose more than 25 years of experience in the Quality Control and Regulatory Compliance, Information Technology, Project Management , Computer Information Manufacturing Systems and Supply Chain consistently lead to the achievement of sustained organizational goals and objectives by developing and manage multi-disciplinary projects in highly matrix and complex environment based in trust, teamwork, sound judgement and effective leadership such as Laboratory Data Acquisition, Quality Management, Laboratory Information Management, Manufacturing Execution, Enterprise Resource Planning systems. Very experienced in developing user requirements, project scope and detailed project management needs and managing large global projects involving diverse teams.


Quality Consultant/Manager - Versatile and solutions-oriented professional with over 30 years of experience in manufacturing, distribution, and financial operations. Over 10 years of experience working in a GxP-validated environment. Over 20 years of programming/design experience. CSV documentation (High Level Risk Assessment, Quality/Validation Plans, URS, FS, DS, FRA, Trace Matrix, IQ, OQ, PQ, Test Summary, Validation Summary). Knowledge of the following functions: Distribution/Supply Chain, ERP, Automated Warehouse Storage and Retrieval (ASRS), Sales Order Processing.


Lead Automation/ Validation Engineer - Operating Systems and Platforms: Microsoft Windows Server 2008, 2012, Unix. Network Technology: Ethernet, TCP/IP, SAN, Microsoft Exchange Server, Routers, Switches, Hubs. Automation, Control Systems Hardware and Instrumentation: Allen Bradley (Controllogix, SLC, PLC, 5/40) GE Fanuc, RTP, DeltaV, ProcessLogix, Experian. Manufacturing Software: Allen Bradley ProcessLogix, RSBatch, Suite of RA Products, Emerson DeltaV, Intellution iFix and iBatch, Wonderware, OSI PI, Werum PAS|X MES, RA ProPack PMX MES.

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