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DescripciónDescription
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 (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.
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Requisitos Requirements
Doctorate or Master's Degree + 2 years of directly related experience or
Bachelor's Degree + 4 years of directly related experience or
Associates + 8 years of directly related experience
Computer Literacy
Bilingual (Spanish/English)
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