CSV Engineer

Roles & Responsibilities 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., Qualifications protocols – Software qualification, Input/Output loop verification, hardware qualification. Review and approve qualification documentation like URS, SLIA (system level impact assessment)/CLIA (component level impact assessment), SRA (System Risk Assessment), DIRA/DSA (Data securit...