CSV Engineer

Job Description: Contribute to Life Science projects for Antaes Asia clients. Work with cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures. Provide guidance and support to establish systems for ensuring Data integrity, compliance to 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 case 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 documentations like URS, SLIA (system level impact assessment)/ CLIA (component level impact assessment), SRA (System Risk Assessment), DIRA/ DSA (Data security, audit trail review), DQ, ...