Descripción del Empleo:
Responsible for ensuring a product or service meets the established standards of quality including reliability, usability and performance
Perform and document Process and Facility Quality Audit in a Packaging, 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 Packaging, 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
Requirements: • Bachelor Degree in Science with a major in Microbiology, Biology, Chemistry or related science
• Minimum of 2 years in Pharmaceuticals environment. At least 6 month in packaging lines
• 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.
Summary:Accountable for monitoring and assuring the Retains Program compliance with established procedures, guidelines, policies and regulatory requirements...
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