Job Information
ThermoFisher Scientific Investigation and Client Quality Specialist II in Ferentino, Italy
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
The resource will be part of a team with multifaceted strengths!
The role will execute the activities of the Quality Operations team responsible for deviation management, Clients and projects also supporting the Supervisor for coordination.
Main activities:
Responsible for achieving the quality objectives
Independently coordinates the projects assigned
performs the training of the personnel involved in the quality operations activities and performs the training, for the topics of its competence, to all site personnel
deals the Deviations, finalizing both personally and can support the review of the investigations performed by the Quality Operations Specialist
Actively collaborate with the Manager, in the search of corrective and/ or preventive actions to achieve maximum efficiency and effectiveness of the processes
Actively participates in the meetings projects, regularly updating colleagues and Responsible for the state of current projects
Participates and/or conducts Client/Regulatory Audits
It is involved for drafting and reviewing Risk Assessment for the assessment of the risks associated with quality events
Organizes and ensures that document review activities (deviations, QAT, SOP) for batch release are performed within the timelines defined by the plan.
Support the revision of Quality Agreements - Client assigned
Act as a quality interlocutor, for each Client/project, in order to provide timely and constant support for QO topics
Provides Client via TC and email support answering quality questions; Collaborate with the business and other colleagues of the PDS BUs in the organization of technical and management meetings with Client
Research, in collaboration with other plant structures, the improvement of processes in the field of "quality continuous improvements" and supports PPI initiatives
Ensures an appropriate revision of the GMP documentation to confirm compliance with current regulations, national and international guidelines and corporate standards
Requirements:
Graduated in CTF, Pharmacy, Biologty, Biotechnology
At least 4/5 years of experience in the same role
Preferred Knowledge of: Investigation process, deviation process, batch record review, QC Out of specification and laboratory event
Fluent knowledge of English
Experience in client management
Preferred experience in team management
Come to work with us!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.