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DescripciónDescription
Specialist QA with expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
Skills:
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, facility, utility, and equipment qualifications.
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Requisitos Requirements
Doctorate degree or Master's degree and 3 years of directly related experience or
Bachelor's degree and 5 years of directly related experience years of directly related experience (Sciences or Engineering)
Bilingual (Spanish/English)(Write/Speak)
Computer Literacy
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