This role is responsible for Quality Assurance Validation (QAV) oversight of Computer Systems and Analytical Instruments validation, including their lifecycle management. It involves validating Computer Systems, GxP software, manufacturing/QC/Bio-Analytical instruments, and process automation systems.
The position requires close collaboration with various departments, guiding project phases, and supporting risk-appropriate qualification strategies.
A broad knowledge of biologic processes, quality engineering, validation, and international regulations is essential. Experience with the following is preferred: