Quality Assurance Specialist - Computerized Systems

September 25

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Description

• Develop and maintain the Quality Management System (QMS) for computerized systems. • Conduct risk assessments and create management plans. • Audit software and IT vendors for compliance. • Lead internal audits. • Validate and qualify computerized systems. • Train consultants and staff. • Manage the software lifecycle. • Liaise with regulatory authorities and stay current on regulations.

Requirements

• Degree in Engineering, IT, Natural Sciences, or related field. • Extensive QA experience with computerized systems. • Strong knowledge of QA principles and regulatory standards (e.g., ICH GCP, FDA 21 CFR Part 11, GAMP5). • Proficient in test and validation techniques. • Excellent English communication skills.