Computer System Validation Specialist

Our organization is seeking an experienced Validation Specialist to lead the validation of computer systems in medical devices applications. The successful candidate will be responsible for ensuring compliance with FDA guidelines and industry standards such as GAMP. About the Role:The Validation Lead will work closely with cross-functional teams to plan,...

System Validation ExpertWe are seeking an experienced System Validation Expert to join our team. This role requires a strong understanding of regulatory requirements and industry standards for Medical Devices.7-10 years' experience in Computer System Validation of Regulatory Information Management systems used in Medical Devices Application of FDA guidance's...

System Validation Expert">We are seeking a highly experienced system validation expert to lead computer system validation projects. The ideal candidate will have in-depth knowledge of regulatory requirements, specifically FDA guidelines and industry standards (GAMP), as well as 21 CFR Part 11 and Risk Based Approach.">The successful candidate will have the...

Seeking a skilled Mainframe Operations specialist to join our team in monitoring, investigating and managing client environments. The ideal candidate will have System Operations/Batch skills, proficiency in CA7/IZWS tools and experience with maintenance changes.Main ResponsibilitiesMonitor and investigate alerts received from clientsManage jobs using...

Job Title: Validation LeadA high-level validation professional is sought after to lead computer system validation projects. The ideal candidate will possess extensive experience in validating regulatory information management systems used in medical devices.7-10 years' experience in Computer System ValidationStrong understanding of 21 CFR Part 11 and Risk...

Job SummaryLead the validation of computer systems in a medical device regulatory information management system environment. Apply FDA guidance and industry standards, such as GAMP, to ensure compliance.7-10 years of experience in computer system validationStrong understanding of 21 CFR Part 11 and risk-based approachExperience in drafting and approving CSV...

**Validation Engineer Specialist****Job Mission**Ensure robust validation for new projects to Brazilian market, attending program needs and key project milestones.As a team, contribute to define and clarify the validation processes aligned with headquarters, generate engineering solutions, reports and develop team members.**Main Responsibilities**Define and...

Nível Acadêmico: Ensino Superior Completo Turno/Horas -- Áreas de Atuação Profissional: TI - Projetos Descrição: 7- 10 years' experience in Computer System Validation of Regulatory Information Management system used in Medical Devices Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk...

Job Title: Validation LeadAbout the Role:We are seeking an experienced professional to lead our system validation efforts. The ideal candidate will have 7-10 years of experience in computer system validation, with a solid understanding of FDA guidance and industry standards.The successful candidate will have expertise in risk-based approaches, software...

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we...