Opportunity Description
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), SRA (sys...