Qa Auditor -Gurabo, Pr

Descripción del Empleo:
• Perform and document Process and Facility Quality Audit in Manufacturing and Utility Areas according to established Procedures, cGMP and company standards.
• Evaluate Process and Facility audit findings and ensure the implementation of appropriate corrective actions (with supervisor).
• Coordinate and conduct AQL Inspection to finish Parenteral Products and monitor testing and inspection of materials and products to ensure finished product quality
• Review of batch records, in-process documents, analytical data and other regulatory documentation to ensure compliance with corresponding Procedures, cGMP and company Standards.
• Ensure that batch records, in-process documents, analytical data, checklists, etc. are filed in an organized manner and easily retrievable.
• Collect and compile statistical quality data as requested
Requisitos:
• Bachelor Degree in Science with a major in Microbiology, Biology, Chemistry or related science
• Minimum of three 2 years in Pharmaceuticals environment.
• Fluent in Spanish and English and excellent ability to write in English and Spanish
• Proficient in the use of MS Office applications Word, Excel, Power Point, Outlook , eLIMS and SAP.
• Statistical knowledge.
• Experience on metric reports and business presentations preparation.