You are able to identify and simplify complex issues.
In this role you support, consult, train on, and lead quality improvement projects throughout the life cycle. This includes product design and development, manufacturing, purchasing and improvements. You utilize statistical tools and techniques to establish sampling plans. You support engineering activities in process and vendor specification development. You analyze process-, product-, test- and Quality Management System data and investigates for improvement opportunities. You will be responsible for pFMEA documentation and leading pFMEA meetings. You review validations documentation eg. IQ, OQ, PQ and verification studies. You lead CAPA investigation and action plans. You lead or are team member of Internal audit observation investigation and action plans. You ensure that software validations are performed according to applicable FDA guidelines and provide end user support by software validation throughout the Software Validation Life Cycle.
University or Bachelor level in engineering or science. Basic statistical analysis tools. 5+ years relevant experience of which 3+ years with Pharmaceutical or Medical Device companies. Knowledge of software and process validations. Knowledge in Statistics. Sufficient knowledge about computer systems and programming with Crystal Reports.
Pro Active. Trouble shooting and Risk Assessment or Risk Management minded. High level of accuracy. Flexible and Service minded. Able to identify and simplify complex issues. Fluent in English, Dutch pre. This role is to prepare for new audit system to use next year, with focus on reviewing documentation, identify gaps and solving these, making the company 'audit-proof'.
Voor meer informatie neem je contact op met Peter Debrichy, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: firstname.lastname@example.org Kenmerk: 7656.
XDES projects is specialist in recruitment van technisch personeel.
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