Equipment Validation Avi Specialist - Monza, Italia - Thermo Fisher Scientific

Thermo Fisher Scientific

Azienda verificata

Monza, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Specific assignments/primary activity:

Joining the Automatic VIsual Inspection and Validation team, you will support the Supervisor in coordinating the Internal Team of specialists and Technicians from external companies engaged in Vision System Validation Activities, through the monitoring and verification of the technical-qualitative result.

Your main focus will be to ensure the correct qualification of the vision systems through the execution of the operational activities envisaged by the Protocols (IQ-OQ-PQ Protocols) and the coordination and supervision of the activities carried out by the other corporate functions, in compliance with the protocols and corporate procedures.

You will completely autonomously support AUDITS, internal customers and Regulatory AIFA/FDA, communicating the documents and procedures relating to the validation flows of the Vision systems.

You will also be involved in the following activities:

Drafting the Qualification Protocols and coordinating the team in the same activity (IQ-OQ-PQ Protocols), involving the company functions in relation to the definition of the activities they will have to carry out, in compliance with company SOPs.
Provides administrative and technical support to Project Team including planning, organizing and coordinating responsibilities of project administration. Maintains procedures, guidelines and documentation. Assists with maintaining project records and ensuring that all regulatory documents are correct, processed and approved. Completes data entry and supports maintenance of data base repositories. Assists in preparing reports and data collection for analysis. Supports quality review.
Carry out a correct analysis of the qualification activities, coordinating the group of specialists, through the collection and analysis of data and results generated in the field, in compliance with company protocols and procedures.
Ensure the correct archiving of all documentation relating to qualifications, through the preparation of validation dossiers. Coordinate the Team in the execution of this activity.
Carry out checks and investigations in the event of nonperformance and exceeding of defect limits, interacting with the appropriate company functions in compliance with the quality standards and regulations in force Perform, with the team of specialists, functional tests and drafting of technical texts to support deviations, change control, optimizations, new processes, etc.
Daily operation of vision systems: verify, through coordination of the internal team of specialists, the correct daily functioning of the automatic vision systems

How you will get there?

Education

Technical Certificate/Degree in Science

Technical and digital literacy

Knowledge of CGMP Knowledge of Regulations concerning the validation of Equipment and Utilities + USP790 & USP1790

Professional experiences:

Proven experience (At least 5 years) in validating equipment, with particular reference to visual inspection machines

Softwares:

Word, Excel, MS Project

Personality traits:

Organization skills Interaction skills propensity for Teamwork Predisposition for the preparation and evaluation of technical documentation

Desiderable