The Qualification & Validation Specialist reports to the Qualification & Validation Supervisor. The Qualification & Validation Specialist "Media fill" is an expert in the role.
The tasks are as follows:
* Design the aseptic process simulation (Media fill, Sterile hold-time, Aseptic manipulation…)
* Supervise the annual program "Media fills"
* Review annually the number and type of aseptic manipulations to be simulated
* Ensure that all activities are performed according to the schedule
* Ensure that all activities are properly documented
* Write validation protocols and reports and other documentation related to the activities
* Investigate deviations and execute CAPAs
* Define and execute improvement projects and initiatives
* Participate in customer and authority audits
* Can be involved in other validation activities