Specialist Quality Assurance Expert
hace 1 mes
Quality Assurance Specialist with expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
Key Responsibilities include Facilities, Equipment and Utilities Validations. Additionally, hands-on experience in electronic systems such as Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
Key Skills include validation of GxP applications, validation master plan, installation qualification (IQ), risk assessment/GxP assessment, operational qualification (OQ), and performance qualification (PQ) protocols, test scripts, and completion/summary reports approvals as per the compliance requirements.
Requirements include doctorate degree or master's degree and 3 years of directly related experience or bachelor's degree and 5 years of directly related experience (Sciences or Engineering). Additionally, bilingual skills in Spanish/English (write/speak) and computer literacy are required.
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