Validation Manager Lazio

Validation Manager
Roma
Lazio, Lazio

Validation Manager, Provincia di FrosinoneProvincia di Frosinone, Italy

Thermo Fisher Scientific, world leader in serving Science, is looking for a Validation Manager for the site in Ferentino (FR).

The successful 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 plants and machinery, in compliance with company protocols and procedures. CalibrazioneEnsure through direction, coordination, and control of the dependent structure the execution of initial calibration and periodic calibration activities of plants 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 potential participation in the audits themselves, in compliance with current GMP regulations. Ensure the continuous updating of SOPs, qualification procedures, and protocols concerning the area of expertise, through the approval of the documentation itself and the 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, the enhancement of results, and the analysis of training and development needs, in order to guarantee a high level of performance and motivation. Support the supervisor in preparing and proposing the function's budget, by providing necessary data and proposing budgets for the area of competence, in compliance with company standards. Solid managerial experience in the field of validations, preferably gained in the pharmaceutical sector. In-depth knowledge of cGMP and relevant EU & US regulations. Excellent knowledge of the English language, both written and spoken.

#J-18808-Ljbffr