For our client in Heist o/d Berg we are looking for a Support in Additional cleaning validation activities.
Job Descriptions
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.
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.
Requirements
Diploma:
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 ).