KEY RESPONSIBILITIES
•Be
responsible for validation activities management including but not limited to
cleanroom validation, sterilization validation, and equipment validation.
•Raw material, in-process quality control and finished
goods inspection, process control handling including quality data collection
& analysis, and quality issue investigation.
•Analyze and report trends related to product quality
and environmental control.
•Change control management, follow up on actions status
until the change order is closed.
•Track and monitor the events. Conduct review activities
and contribute through to closing all events.
•Manage the measuring and monitoring equipment and maintain
the inspection equipment and gauges.
•Maintain oversight of the complaints and daily processes
to ensure issues are being addressed in a timely and thorough manner, and
conform to the company complaint policy and procedures.
•Manage corrective and preventive action system,
systematically follow up the corrective and preventive action system and report
the system performance.