Cleaning Validation Engineer

il y a 5 jours


Geel, Belgique Arcadis Temps plein

Tasks: Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities. Develops, implements and executes validation studies for cGMP-critical process systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this. Perform validation of systems in scope for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP's and company Procedures. Ensures that the Validated Status of process systems in scope is in compliance with cGMP at all times. Ensures projects are supported in conjunction with all required company and cGMP regulatory standards. Keep current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provide technical assistance on current US FDA and EU validation requirements. Generate validation documentation (protocols/reports) and provides assistance with the execution of protocols for systems in scope using Kneat paperless validation tool. Responsible for the validation documentation through approval and implementation. Provide input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate. Skills Knowledge of CGMP requirements in a regulated environment. Understanding of relevant quality and compliance regulations. Capable of troubleshooting validation issues. Experience: 2-4 years experience working in a pharmaceutical sector and GMP environment Important information Experience with the validation of Clean Steam Generator system and Parts washers is an advantage Good knowledge of English and Dutch


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