Validation Manager Lazio

Validation Manager
Roma
Lazio, Lazio

Thermo Fisher Scientific, world leader in serving science, is looking for a professional for the site in Ferentino (FR).

The candidate will be responsible for the following activities:

Qualifica/RiqualificaEnsure, through direction, coordination, and control of the dependent structure, the execution of qualification/requalification activities of systems and machinery, in compliance with company protocols and procedures. CalibrazioneEnsure, through direction, coordination, and control of the dependent structure, the execution of first calibration and periodic calibration activities of systems and machinery, in compliance with company protocols and procedures. Provide support in the preparation and participation in audits by external entities, through direction, coordination, and control of the dependent structure in providing necessary information and documentation and through possible participation in the audits themselves, in compliance with current GMP regulations. Ensure continuous updating of SOPs, qualification procedures, and protocols regarding the area of competence, through the approval of the documentation itself and direction, coordination, and control of the dependent structure in drafting and updating the procedures and SOPs related to the areas of competence, in compliance with current regulations (laws, EU and international GMP standards, etc.

). Gestione del personale dipendenteEnsure direction, coordination, and control of the dependent structure, through the definition of objectives, valuing results, and analyzing training and development needs, in order to guarantee a high level of performance and motivation. Support the superior in preparing and proposing the function's budget, through the provision of necessary data and the proposal of the budget for the area of competence, in compliance with company standards. Consolidated managerial experience in the field of validations, preferably gained in the pharmaceutical sector. In-depth knowledge of cGMP and relevant EU & US regulations. Excellent command of the English language, both written and spoken.

#J-18808-Ljbffr