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DescripciónDescription
▪Develop validation documentation such as protocols, reports, procedures, etc.
▪Coordinate and work with the corresponding functional areas to assure validation activities execution.
▪Execution of validation protocols (IQ/OQ/PQ/TFIQ/TMV), feasibility studies, metrology.
▪Processing through the Ignite System all changes on drawings, part, structures, documents, protocols
and risk management in timely manner.
▪Investigate nonconformities (such as deviations and failures) related to the area including root cause
analysis and report findings.
▪ Protocols closing
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Requisitos Requirements
▪Minimum Engineering Degree in one of these fields (IE, EE, ME)
▪Previous related experience, such as validation/qualification activities, good documentation practices,
clean room, medical device.
▪Excellent computer skills required.
▪Ability to read, comprehend, write and speak English, and good communication skills and
interpersonal skills required.
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