Issuing and execution of qualification protocols (IQ / OQ) of machines and plants;
Issuance and execution of qualification protocols (PQ) for utilities;
Interface with Quality Assurance for all issues with GMP relevance;
Fronter in the event of Audit by external regulatory bodies.
To excel in this role you will need to have
Excellent knowledge and experience in the application of the main safety regulations “testo unico per la sicurezza”, machine directive, ATEX and PED regulations;
Knowledge / experience in pneumatics, hydraulics, basic electromechanics, electrical switchboard, motion control, industrial instrumentation;
Knowledge and proven experience of process control technologies / machines / utilities (SCADA, PLC, industrial PC);
Knowledge of the main structured and object oriented programming languages (Pascal, C ++, PHP, Java, Java Script);
Master’s degree in electronic engineering, computer science or electrical engineering;
Experience of at least 3/5 years in the role;
Excellent knowledge of the most widespread IT tools such as Office,, SAP;
Excellent knowledge of English;
Knowledge of pharmaceutical processes, GMP and HSE standards and Lean Manufacturing;
Attitude to achieving challenging goals, team working and integrity;
Ability to manage time / priority / projects and stress;
Tension to results and continuous improvement;
Problem solving and a strong aptitude for flexibility.
It would be advantageous to have (not essential)
The knowledge of French will be considered as a plus.
Tagged as: Validation&Automation Manager
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