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:
Defines and manage the equipment and utilities requalification plan.
Plans and performs the qualification of new or modified equipment, utilities and computerized systems.
Drive the suppliers in the qualification activities of the new or existing equipment.
Collaborates with the Engineering team and other departments like QA, MS&T, Production to develop validation master plans, standard operating procedures, and other GMP documents.
Collaborates with the Engineering team and other departments like QA, MS&T, Production to manage Deviations, CAPAs and Change Controls.
Analyzes and conduct risk assessments supporting the Engineering projects.
Analyzes and conduct risk assessments supporting the Maintenance activities.
Supports 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.
Assists in training operators or other staff on qualification protocols and standard operating procedures.
Participates in internal or external training programs to maintain the knowledge of qualification principles, industry trends, or best technologies.
Requirements
Essential requirements:
Priority system knowledge and management.
Quality Management System knowledge (GMP, GDP, Data Integrity) and duly application in all activities performed.
Knowledge of Environment, Health and Safety principles and applicable main EHS local regulations.
Full compliance with TEVA Ethic Code and Values.
Education:
Engineering Degree – preferably Chemical or equivalent technical degree
Languages:
English and Italian (good level of proficiency)
Skills:
Objectives focused with excellent planning and organizational ability.
Good communication skills with attitude to work cross-functionally in a complex and variable environment.
Day-by-day high focus together with mid-long term view.
Good attitude to planning and prioritization in alignment with business and customer needs.
IT systems familiarity.
Experience:
3 years’ experience preferably within relevant industrial production environment.
3 – 5 years’ experience in Qualification and GMP Compliance area
Quality Management System knowledge (GMP, GDP, Data Integrity) and duly application in all activities performed.
