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Specialist QA - Juncos - Administrative shift-34374

Specialist QA - Juncos - Administrative shift-34374

Integrated Services For Productivity & Validation, IncJuncos, PR, pr
Hace 25 días
Descripción del trabajo
  • 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.
  • 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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