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Validation Manager

2 mesi fa

Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pieno
About the Role

Thermo Fisher Scientific is seeking a highly skilled Validation Manager to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the execution of qualification and requalification activities, calibration, audits, and procedure development in compliance with company protocols and procedures.

Key Responsibilities
  • Qualification and Requalification: Ensure the execution of qualification and requalification activities of plants and machinery, providing guidance, coordination, and control to the dependent structure.
  • Calibration: Ensure the execution of first calibration and periodic calibration activities of plants and machinery, in compliance with company protocols and procedures.
  • Audit Support: Provide support in the preparation and participation in audits by external entities, guiding the dependent structure in providing necessary information and documentation.
  • Procedure Development: Ensure the continuous updating of SOPs, qualification procedures, and protocols, approving documentation and guiding the dependent structure in drafting and updating procedures.
  • Team Management: Ensure guidance, coordination, and control of the dependent structure, defining objectives, enhancing results, and analyzing training and development needs.
  • Budget Support: Support the Superior in the preparation and proposal of the function's budget, providing necessary data and proposing budgets for the area of competence.
Requirements
  • Consolidated managerial experience in the field of Validation, 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.