Validation Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Thermo Fisher Scientific, world leader in serving Science, is looking for a Validation Manager for the site in Ferentino (FR). The candidate will be responsible for the following activities:

Qualification/Requalification Ensure the execution of qualification/requalification activities for plants and machinery by directing, coordinating, and controlling the dependent structure, in compliance with company protocols and procedures. Calibration Ensure the execution of initial calibration and periodic calibration activities for plants and machinery by directing, coordinating, and controlling the dependent structure, in compliance with company protocols and procedures. Audit Provide support in the preparation and participation in audits by external entities by directing, coordinating, and controlling the dependent structure in providing necessary information and documentation, and potentially participating in the audits themselves, in compliance with current GMP regulations. Procedures Ensure the continuous updating of SOPs, qualification procedures, and protocols related to the area of competence by approving the documentation and directing, coordinating, and controlling the dependent structure in drafting and updating the procedures and SOPs relative to the areas of competence, in compliance with current regulations (laws, EU and international GMP standards, etc.). Personnel Management Ensure the direction, coordination, and control of the dependent structure by defining objectives, enhancing results, analyzing training and development needs, to ensure a high level of performance and motivation. Budget Support the superior in preparing and proposing the budget for the function by providing necessary data and proposing budgets for the area of competence, in compliance with company standards. Requirements: Consolidated managerial experience in the field of validations, preferably in the pharmaceutical sector.In-depth knowledge of cGMP and EU & US reference regulations.Excellent command of the English language, both written and spoken.
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