Technical Services Quality Support Specialist

Job Description

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

Ferentino, Italy

Discover Impactful Work:

Ensure the Quality of the Technical Area Departments, dealing in particular with the management of Customer Audits and Regulatory Inspections, Deviations, CAPAs, Changes, SOPs relating to Process Maintenance and Utilities, Calibrations and Equipment Qualification.

A day in the Life:

• Support the Quality Department in preparing, managing and actively participating in Customer Audits and Regulatory Inspections.
• Support the Technical Departments (Equipment Qualification and Maintenance) in increasing their Quality Culture, helping them with Deviations, CAPA, Change, SOP, Training, Risk assessment and Data Integrity.
• Analyze the historical data and results of the qualification and maintenance activities.
• Assure the protocols, reports and SOPs are in compliance with current regulations (current EU GMP, US GMP) and company quality standards.
• Participate in calls/meetings with customers/auditors to support the discussion on quality topics for Technical Departments.
• Collaborate with the Team Leader to identify and solve the quality gap of Technical Departments.

Keys to Success:

Education

• Technical / Scientific Degree (Mechanical Engineering, Chemical Engineering, CTF, Biomedical Engineering, Pharmacy, Industrial Chemistry)

Experience

• Experience in pharmaceutical industries including Audit/Inspection participation
• At least 2 years’ experience in Validation or Quality 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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.