We are seeking a senior QA specialist who will play a critical role in driving compliance and quality across the organization's biometric services and computer systems. This role involves hands-on execution of QA activities, leadership in audits and risk management, and close collaboration with cross-functional teams such as data management, biostatistics, statistical programming, software development and validation, and IT and security.
The senior QA specialist will ensure that processes, computer systems, and deliverables adhere to GxP, ICH-GCP, 21 CFR Part 11, and other applicable regulations, as well as internal quality standards through proactive oversight, documentation review, system validation, and continuous process improvement.
Essential Functions And Responsibilities
Document & Process Auditing
Conduct and/or host internal audits and vendor audits
Review and audit Trial Master File (TMF) for completeness, accuracy, and compliance
Track and report audit findings, deviations, and CAPAs (Corrective and Preventive Actions)
Perform risk-based audit planning and inspection readiness assessments
SOPs, Policies and QMS Maintenance
Review and assist in developing policies, SOPs, work practice documents, forms and other Quality Management System (QMS) documents
Ensure alignment with the company's Quality Policy and applicable external regulations
Ensure controlled documents are reviewed periodically and in a timely manner
Document and manage deviations, nonconformances, and CAPAs
Maintain quality records and support archiving in accordance with regulatory timelines
Training Management
Collaborate with functional managers to establish and periodically review training curricula, including study-specific training for internal teams
Monitor overdue training, and follow up with individuals and their supervisors until completion
Computer System Validation Support
Participate in validation planning and execution for internal and customer-facing systems
Collaborate with
📌 Senior Clinical QA Specialist (Perú)
🏢 EDETEK
📍 Perú