Specialist, Equipment Validation
1 settimana fa
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Location/Division Specific Information**:
Ferentino, Italy
**Discover 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 system to be qualified in order to acquire information necessary for the issue of protocols and the execution of activities.
- Issue of qualification protocols (IQ-OQ-PQ Protocols), through research and acquisition of data and information necessary to define their contents.
- Lead the external consultants in order 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 in order to achieve the goal of the company's projects.
- Participate in calls/meetings with customers/clients to support the discussion on topics related to equipment qualification.
- Collaborate with the Team Leader to close on time all assigned project.
**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
- Be prepared to work with conflicting priorities, under time constraints and in a dynamic team environment
**Benefits**:
We offer competitive remuneration, 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. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation
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