Validation Specialist
Há 2 dias
Summary The Validation Specialist is responsible for creating and updating validation documents (internal protocols, Installation Qualification (IQ), Operational Qualification (OQ), Change Controls) to ensure that OPTEL systems comply with industry standards. This role requires strong expertise in documentation as well as the ability to collaborate effectively with internal teams and clients to ensure compliance, quality, and project reliability. Responsibilities Develop and maintain standardized validation templates that comply with industry standards and regulatory requirements (GAMP, FDA 21 CFR Part 11, EU Annex 11). Review and interpret system updates (new releases, patches) to assess their impact on validation documents. Produce validation documents for clients based on functional and design specifications of projects. Execute internal validation protocols as needed to ensure system functionality and compliance. Risk Analysis and Quality Improvement Actively participate in risk assessments to identify validation‑related issues and define necessary mitigation plans. Identify root causes of validation nonconformities and deploy corrective actions with a focus on continuous quality improvement. Collaboration and Expertise Coordinate with various internal departments to deliver validation documentation at key project milestones. Advise internal teams and clients on best practices and validation strategies. Work in collaboration with the Quality Assurance (QA) team to ensure compliance with internal and regulatory standards, including participation in internal and external audits. Perform any other related tasks associated with validation processes. Required Skills College diploma in a relevant field or equivalent experience. Minimum of 2 years’ experience in system validation/testing or technical writing. Proficiency in Portuguese and English. Advanced knowledge of Microsoft Office Suite (Word, Excel); rigor, analytical mindset, and attention to detail. Ability to collaborate effectively in a team and communicate with stakeholders at all levels. Strong curiosity and willingness to learn and adopt new technologies, especially artificial intelligence. Advantages and Benefits Flexible work schedules. Remote working mode. Competitive compensation. Healthcare plan. Life Insurance. Meal allowance (Ticket). Wellhub. Seniority Level Entry level Employment Type Full‑time Job Function Quality Assurance Industries IT Services and IT Consulting #J-18808-Ljbffr
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