Systems Validation Specialist II

🕒 Setembro 29

🌐 Argentina, México – Remoto

🇦🇷 Argentina – Remoto 🇲🇽 México – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👻 Score fantasma 10%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Parexel

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1983

💼 Consultoria

🏥 Saúde

📦 Logística

💰 Venture Round em 1990-01

Consulting • Healthcare • Logistics

Parexel é uma das maiores organizações de pesquisa clínica (CROs) do mundo, oferecendo serviços abrangentes para o processo de desenvolvimento clínico das Fases I a IV. A empresa é especializada em gestão de portfólio, gestão de ensaios clínicos, estratégia regulatória, acesso ao mercado e gestão do ciclo de vida para biofarmacêuticos. A Parexel busca acelerar a chegada de medicamentos que transformam vidas ao mercado, alavancando sua expertise clínica, regulatória e terapêutica. Com uma equipe global de mais de 21. 000 profissionais, a Parexel trabalha para integrar insights de pacientes e desenhos de estudo inovadores a fim de desenvolver tratamentos em áreas terapêuticas como oncologia, neurociência, doenças raras, entre outras. Seu foco está na condução de ensaios clínicos eficientes e centrados no paciente.

Descrição

• Act as a custodian and leader of the Parexel Quality System and serve as an ambassador for quality across the business and with customers • Support the development, implementation, and management of Parexel strategic objectives • Establish and maintain a communication framework that removes constraints and supports timely, effective action on quality matters • Collaborate with functional leads to design, re-engineer, implement, and adopt the quality framework for validation and release of interfaces and solutions • Lead activities to identify low- and medium-risk or value improvements for process architecture, including Standard Operating Procedures, manuals, and related quality system documentation • Support the development, implementation, continuous improvement, training, and adoption of infrastructure, change control, and problem management processes • Provide guidance, consultation, and quality expertise to project teams supporting clinical trial and validation activities across the applicable lifecycle • Support oversight and monitoring of compliance status and activities for projects, business areas, or portfolios, including validation planning, resource estimates, risk and impact assessments, summary reporting, and Electronic Records/Electronic Signature regulations • Assist with risk mitigation by identifying, categorizing, and defining risks and associated mitigation plans • Support internal customers with technology-related Quality Issue management, including issue descriptions, classification, root cause analysis oversight, and consultation on corrective and preventive actions

🎯 Requisitos

• 3+ years of experience in clinical research and/or clinical trials with emphasis on GCP and technology compliance • Familiarity with technology as it relates to clinical trial activities, including the System Life Cycle process and applicable GCP regulations pertaining to computer systems • Basic knowledge of continuous improvement methodologies • Competency across core project management activities • Degree-level education in technology, biological science, pharmacy, or another health-related discipline preferred; an equivalent qualification • High ability to prioritize workload and manage multiple and varied tasks with enthusiasm • Mid-level experience in computer technology quality and compliance and the pharmaceutical industry across multiple disciplines within Clinical Drug Development and/or Manufacturing • Excellent interpersonal, verbal, and written communication skills • Business understanding and negotiation skills • Strong organizational skills • Ability to work in a customer-focused, fast-paced, rapidly changing, and global environment • Intermediate desktop software skills, including MS Office, Excel, and Adobe PDF • Experience across Clinical Drug Development Phases I, II, III, and/or IV and/or Manufacturing preferred • Knowledge of project management, Lean Six Sigma, auditing, and/or risk management methodologies preferred • Cultural awareness and ability to think and work globally preferred

🏖️ Benefícios

• Flexible work arrangements, including remote work • Opportunities for professional growth and to deepen expertise in computerized system validation, technology compliance, quality systems, project management, auditing, and risk management • Opportunities to contribute to clinical research across multiple phases of drug development