Specialist Qa

Specialist QA with expertise in Quality Systems such as Deviations (Non-Conformities, CAPA and Change Control).Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, Electronic Batch Record (EBR) and SAP.Experience with Validation of GXP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessments/GXP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.Validate exprience as Quality Control for sophisticated projects involving new drug substance/products with experience in commissioning and qualifications. Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.Requisitos:Doctorate degree or Master's degree and 3 years of directly related experience orBachelor's degree and 5 years of directly related experience (Educational background in Life Science and/or Engineering)Bilingual (Spanish/English)(Written/Verbal)Technical WritingFacilitation and presentation skills.