Requirements: English
Company: Thermo Fisher Scientific
Region: Ferentino , Lazio
Job ResponsibilitiesEnsure the quality of the Technical Area Departments, focusing on Customer Audits and Regulatory Inspections, Deviations, CAPAs, Changes, SOPs related to Process Maintenance, Utilities, Calibrations, and Equipment Qualification.Support Technical Departments (Equipment Qualification, Calibration, and Maintenance) in enhancing their Quality Culture by assisting with Deviations, CAPA, Change Management, SOPs, Training, Risk Assessments, and Data Integrity. Analyze historical data and results of qualification and maintenance activities. Ensure protocols, reports, and SOPs comply with current EU GMP, US GMP regulations, and company standards. Collaborate with the Team Leader to identify and address quality gaps within Technical Departments. Assist in preparing for Customer Audits and Regulatory Inspections.QualificationsTechnical/Scientific Degree (Mechanical Engineering, Chemical Engineering, CTF, Biomedical Engineering, Pharmacy, Industrial Chemistry).Experience in the pharmaceutical industry.Preferably 6 months experience in Qualification, Calibration, Engineering, or Maintenance Departments within Pharmaceutical or Consulting Companies.Knowledge, Skills, and AbilitiesKnowledge of main pharmaceutical machines and systems.Proficiency in English.Strong teamwork skills.Excellent problem-solving abilities.Proficiency in Microsoft Office Suite.#J-18808-Ljbffr