Main responsibilities and activities
In the Engineering Department we are looking for a brilliant profile reporting to the Site Engineering Head with the following responsibilities and activities:
Define and manage the equipment and utilities requalification plan.
Lead the qualification of new or modified equipment, utilities and computerized systems.
Manage and drive the suppliers in the qualification activities of the new or existing equipment.
Supervise temperature mapping activities for equipment, warehouses and climatic chambers
Collaborate with the Engineering team and other departments like QA, MS&T, Production to develop validation master plans, standard operating procedures, and other GMP documents.
Collaborate with the Engineering team and other departments like QA, MS&T, Production to manage Deviations, CAPAs and Change Controls.
Analyze and conduct risk assessments supporting the Engineering projects.
Analyze and conduct risk assessments supporting the Maintenance activities.
Support the Maintenance Manager to review the preventive maintenance plan based on the results of equipment qualification or the periodic annual review of equipment and utilities.
Assist in training operators or other staff on qualification protocols and standard operating procedures.
Participate in internal or external training programs to maintain the knowledge of qualification principles, industry trends, or best technologies.
Requirements
Quality Management System knowledge (GMP, GDP, Data Integrity) and duly application in all activities performed.
Knowledge of equipment and utilities qualification best practices
Knowledge of Environment, Health and Safety principles and applicable main EHS local regulations.
Full compliance with TEVA Ethic Code and Values.
English and Italian knowledge.
