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Operates instrumentation in order to assist in protocol execution/perform validation activities, including the collection of samples.
Calibrates critical processes instruments and equipment in order to drag and prepare documents on calibration that fulfils validation requirement in relevant protocols.
Prepares written reports/summaries from validation
studies in order to perform propre data analysis. Documents internal and external scheduled validation field activities to ensure proper execution.
Liaises with external validation contractors in order to ensure conformance of activities to procedures and processes.
Conducts activities as related to the defined procedures and standards within own area of responsibility and consults the supervisor to take corrective actions when necessary.
Stays updated with regulatory and quality standards, evolutions in GXP compliance and best practices in order to support management in critical documents and CAPA.