Your Role:
As QA Validation Specialist, you will be the quality reference in the management of site Computerized Systems, overseeing validation activities around equipment and CS to ensure compliance with GMP, FDA, EMA, and other regulations. You will support Operations and Technical Services with root cause investigation of deviations and nonconformities concerning validation and risk assessments and implementation of mitigation strategies. Moreover, you will be responsible for encouraging a continuous improvement culture; providing expertise in the review of validation protocols, reports, and investigations carried out during processing problems and deviations. You will also support the definition and monitoring of Key Performance Indicators and dashboards to help measure progress, in terms of cycle time and compliance-related metrics.
Who you are:
* Scientific degree (e.g., Pharmacy, Biology, or Chemistry)
* 1-3 years’ experience in the pharmaceutical industry with particular knowledge in QA and CSV
* Profound customer orientation with an eye for the company’s own interests
* Flexibility and keen pursuit of innovation throughout all processes in the continuous search for sustainable new ideas
* Strong desire to develop and grow by way of taking responsibility and engaging in additional tasks and operations
* Fluent in Italian and English
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