CSV Engineer

Responsibilities

• 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 A...