Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeLocation/Division Specific InformationFerentino, ItalyDiscover Impactful Work:Ensure the execution of the qualification activities of the Site Equipment reported in the written protocol.
Assure the tests are in line with the main guidelines and GMP.A day in the Life:Perform the analysis and evaluation of technical documentation for systems to be qualified in order to acquire information necessary for the issue of protocols and the execution of activities.Issue qualification protocols (IQ-OQ-PQ Protocols), through research and acquisition of data and information necessary to define their contents.Lead external consultants to assure the correct qualification of the system/equipment (IQ-OQ-PQ Protocols).Carry out the analysis of the qualification activities and issue the qualification reports (IQ-OQ-PQ report), in compliance with current regulations (current EU GMP, US GMP) and company quality standards.Support the Quality Department in preparing Customer Audits and Regulatory Inspections, providing necessary information and documentation.Collaborate with other Site Departments to achieve the goals of the company's projects.Participate in calls/meetings with customers/clients to support discussions on topics related to equipment qualification.Collaborate with the Team Leader to close on time all assigned projects.Keys to Success:Education:Technical / Scientific Degree (Mechanical Engineering, Chemical Engineering, CTF, Biomedical Engineering, Pharmacy, Industrial Chemistry).Experience:Experience in pharmaceutical industries.At least 2 years' experience in Equipment Qualification Department.Knowledge, Skills, Abilities:Knowledge of the main pharmaceutical machines/systems.Fluent in English.Good team worker.Good problem-solving abilities.Proficiency in Microsoft Office suite and electronic systems such as Documentum and Trackwise.Prepared to work with conflicting priorities, under time constraints, and in a dynamic team environment.Benefits:We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits.
Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
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