IT Assurance Analyst, QMS Applications

🕒 Junho 9

🤠 Texas – Remoto

🤠 Texas – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🧐 Analista

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ICU Medical

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

⚕️ Seguro de Saúde

💊 Farmacêutico

Healthcare Insurance • Pharmaceuticals • Medical

A ICU Medical é líder global em terapia intravenosa (IV), especializada em produtos médicos e tecnologias inovadoras que melhoram a segurança e a eficiência da terapia IV em diversos ambientes de cuidado. Fundada em 1984 por clínicos, a empresa é dedicada a oferecer soluções clinicamente relevantes, incluindo bombas de infusão, software de segurança e dispositivos de acesso vascular. O compromisso da ICU Medical em aprimorar o cuidado ao paciente se reflete em seu portfólio abrangente que abrange terapia de infusão, manejo das vias aéreas, monitoramento hemodinâmico e gestão de temperatura, garantindo que os clínicos possam enfrentar eficazmente os diversos desafios do cuidado ao paciente.

Descrição

• The IT Assurance Analyst provides CSV/Assurance support for computerized systems, networks and software that have been newly installed, upgraded and/or modified to support cGMP functions in Manufacturing, Supply Chain, and Quality, as part of IT Quality and Compliance organizations. • This role works closely with Change Owners to generate and support validation/assurance testing (IQ, OQ, IOQ, PQ etc.) that are compliant with Plant and Corporate policies and procedures. • Responsible for reviewing, executing, documenting and approving assurance testing/validation deliverables, and if necessary, coordinate other resources in validation documents and activities.

🎯 Requisitos

• Working knowledge of Oracle Agile PLM and Oracle EBS required. • Working knowledge of data migration and sampling methods preferred. • Process improvement training preferred. • Resourcefulness and problem‑solving skills, with the ability to navigate identify inefficiencies and ambiguity, remove obstacles, and deliver outcomes through innovative, forward‑thinking planning needed. • Experience in one of the following disciplines required: Quality, Manufacturing, Facilities/utilities, Pharma/Solution processes, Sterilization, IT Applications and/or Controls systems/software. • Experience and functional knowledge of Good Automated Manufacturing Practice (GAMP), cGMP, SDLC, Risk Assessment, EU Annex 11, ISO 13485 and/or 21 CFR Part 11 Electronic Records and Electronic Signatures needed. • Good organizational, presentation, meeting facilitation, and technical writing skills required. • Attention to details and the ability to proofread and audit validation documents required. • Familiarity with automation tools preferred.

🏖️ Benefícios

• Must be at least 18 years of age. • Bachelor's degree in Computer Science, Information Systems, Engineering, or a related field from an accredited college or university is required. • Experience in ERP systems development, change, implementation, and lifecycle management – preference to Oracle EBS and Agile applications. • 4+ years of experience in Computer System Validation/ testing in one of the following – Manufacturing, Lab/Facilities, Pharma/Solution processes, Sterilization, Controls systems. • Familiarity with regulatory requirements related to 21 CFRs - Part 11, 820, 210/211, EU Annex 11 and ERES/ Data Integrity requirements. • Experience working with SOX, Data Privacy and Security requirements a plus. • Ability to collaborate and communicate with a variety of key stakeholders (IT, Manufacturing, Quality, Supply Chain, Logistics, Finance, Internal Audit). • Familiarity with Test Management tool (e.g., ValidationMaster), MS Excel and/or SQL queries preferred. • Demonstrable experience of working well in a dynamic, demanding environment with minimal supervision and high resourcefulness. • Demonstrable experience in balancing multiple priorities and delivering timely, high-quality outcomes.