Senior QA Analyst I

Job Description

Provide advice, interpretation, help and training to other departments, in GCP, SOPs, regulatory issues and internal company policies related to Quality Assurance. Lead and manage the QA aspects of IT system validation activities, including document review, filing, system uploads, and approvals, ensuring compliance with relevant regulations (e.g., GCP). Maintain QA databases and electronic file systems related to IT system validation, change control, and audit trails. Oversee and maintain the IT system inventory list, ensuring accuracy and completeness of all documented systems. Independently manage the IT system change control process, including review, assessment, and approval of changes to validated systems. Provide expert advice, interpretation, and training on CSV requirements, GAMP 5 principles, and relevant regulatory guidelines Create, update and collect SOPs, templates and forms/documents. Participate in and contribute to the review and follow-up of corrective and preventive action plans (CAPAs) arising from IT system audits, deviations, and regulatory inspections. Support the Quality Assurance team in the coordination of internal and external audits, including readiness activities specific to IT systems and CSV. Assist in audit preparing activities such as Quality Assurance Administrative Tasks (Agenda, audit plan), readiness of the QMS data, data collection, follow up activities and assisting other departments Track and ensure compliance with timelines for IT-related quality activities, including system reviews, approvals, and training Support cross-functional teams (e.g., IT, Data Management) in ensuring the quality and compliance of computerized systems throughout their lifecycle. Manage the end-to-end process for training within the Learning Management System (LMS), including creation, assignment, and disabling of training. Contribute to the development and monitoring of Quality Key Performance Indicators (KPIs) related to IT system compliance and identify areas for improvement. Follow up on compliance with the times and manner of the employees in terms of revision, signature or training on issues of Quality Assurance. Assist the Quality Assurance Department with completing all required tasks to meet departmental and project goals e.g.: planned audit reports, Controlled Documents targets, preparation of quality metrics and annual reports; overdue response, training compliance, scheduling/maintaining calendar, email correspondence, etc. Any other reasonable task that derives from the previous ones or the position requires.