CSV Engineer

CSV Engineer – Consultant position
Job Description:
Contribute to Life Scienceprojects for Antaes Asia clients
Work with cross functional team in providingQuality oversight in computerized systemlife cycle procedure and ensure compliance to GXP standards and company policies and procedures.
Provide guidance and supportto establish systemsfor 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 Computersystems. -e.g. Qualifications protocols – Softwarequalification, Input/Output loop verification, hardware qualification.
Review and approve qualification documentations like URS, SLIA (system level impact assessment)/ CLIA (component levelimpact assessment), SRA (System Risk Assessment), DIRA/...