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Specialist QA - Juncos - Administrative shift-34374
Integrated Services For Productivity & Validation, IncJuncos, PR, prHace 26 días
Descripción del trabajoExpertise 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 (MES) and SAP Experience with 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. Validated experience as Quality Contact for sophisticated projects involving new drug substances / 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. Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.
Requirements
Doctorate OR Masters + 2 years of directly related experience
Alternatively, Bachelors + 4 years of directly related experience
Alternatively, Associates + 8 years of directly related experience
Educational background in Life Science and / or Engineering.
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Qa Specialist • Juncos, PR, pr