Periode: 2 year project
Our client is active in the food, life sciences, infrastructure, oil and gas and (petro) chemical markets by delivering:
- Support through consulting & engineering;
- delivering turnkey automated solutions;
- maintenance and support.
- Writing the Qualification Plan, Requirement Specifications, User Acceptance test protocol and Qualification Report will be part of your work;
- you are responsible for compliance with the client's requirements and the validated state;
- interpretation of the compliance will be agreed with the Quality Officer;
- reporting progress deviations to the project leaders;
- co-development of the validation strategy for the validation of an existing production plant and a number of improvements / modifications to the various software applications;
- creates documents of such as validation master plan, risk analyzes, summary reports, requirements specifications;
- closely follows the progress of the project and reports the status to the project management and management.
- Experience in working according to specific guidelines and rules (eg GMP, GLP, GAMP);
- user experience in software applications in a GMP environment (such as document management systems, MES, ERP, LIMS, BMS, EBR, data history, etc.);
- a broad general ICT / automation knowledge (eg data exchange, data security, infrastructure, PLC, SCADA, MES systems, etc.);
- familiar with work according to GAMP5;
- aware of the current insights regarding 21 CFR-Part11;
- communicate in English fluently.