Job Description

• Contribute to Life Science projects for Antaes Asia clients.
• Work with cross‑functional teams in providing quality oversight in computerized system life cycle procedures and ensure compliance with GXP standards and company policies and procedures.
• Provide guidance and support to establish systems for ensuring data integrity, compliance with CSV Plan and 21CFR Part 11.
• Act as one of the key focal points for CSV topics such as deviations, change management, investigations, CAPA identification and closure, and as a subject‑matter expert.
• Generate, review, and execute protocols/test cases for initial validation programs related to GXP computer systems, e.g., qualification protocols – software qualification, input/output loop verification, hardware qualification.
• Review and approve qualification documentation such as URS, SLIA (system level impact assessment)/CLIA (component level impact assessment), SR...