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Qc analysis reviewer - clinical trial manufacturing

Monza
Thermo Fisher Scientific
Pubblicato il 7 gennaio
Descrizione

PURPOSE OF THE POSITION / RESPONSIBILITY: Based on the information received from the Manager and / or the Team Leader of the reference BU, it carries out the tasks and activities listed below for which it has been enabled by the appropriate training, in compliance with the company and departmental SOPs and the safety regulations in force. SPECIFIC TASKS / PRIMARY ACTIVITIES: - Implement the verification and evaluation activities of the analytical documentation issued by the laboratory in order to ensure the integrity of the data, through the correct programming of daily activities, the control of the progress of the activities, in compliance with the priorities defined by their manager and company quality standards. - Ensure the correct management of the relevant analytical documentation, from receipt, to control, archiving and traceability, according to current procedures and company quality standards. - Contribute to the optimal technical training of laboratory staff, both in the insertion phase and on the occasion of the introduction of new tools, in compliance with company standards. - Operate, under the supervision of the direct superior, in order to comply with the procedures defined internally on the basis of the NBF and the agreements established with customers. - Depending on the schedule received from your manager, support the team by performing analysis. REQUIREMENTS AND QUALIFICATIONS: - Diploma of chemical expert, Degree in Chemistry / CTF - In-depth knowledge of the most common analytical techniques and required instrumentation (HPLC, UV-VIS, FT-IR) - Knowledge of the Empower system for chromatographic data management - Knowledge and confidence on activities related to analytical transfer, validation of analytical methods and cleaning validation - Knowledge of company procedures and GMPs - Knowledge of laboratory concepts and computer programs - Knowledge of data management and evaluation systems

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