For our client in Heist o/d Berg we are looking for a Support in Additional cleaning validation activities.
After having processed the Standard Operating Procedures (=Safety & Quality) that are relevant for the scope of this assignment and qualification for writing, reviewing, approving and executing protocols and reports, please find beneath the scope of responsibilities.
- Participating during functional meetings that are needed to perform the activities in scope of this assignment.
- Routinely working hours during the day shift at the manufacturing site; however some activities are also being performed at the production shop floor, thus working in an early/late shift is possible (exceptional during night/weekend shift).
- Performing periodic reviews of cleaning processes at three production departments, to control the validated state.
- Coordinating and executing yearly re-qualification studies at the sterile production department.
- Providing support to cleaning projects (development & validation). Cleaning methods in scope are: Parts Washers,Clean In Place, Manual.
- Coordinating the different activities together with validation, production and laboratories: making appointments with production and laboratories, creation of LIMS requests, execution of studies, evaluation study data results.
- Providing support to the monitoring program for potential cross contamination of active compounds by sampling non-product contact surfaces per approved protocols.
- Bachelor in Chemistry/Biology/Biomedical oriented studies or equivalent through experience
- Pharmacist or Industrial/Chemical Engineer (Process techniques, Chemistry, Biology,..)
Existing right to work in Europe required ( please read job spec in full before applying ).