Qualification Engineer

at  Teva Pharmaceuticals

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Qualification Engineer
Date: Jul 2, 2024
Location:Rho, Italy, 0000
Company: Teva Pharmaceuticals
Job Id: 56847

WHO WE ARE

TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry’s broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service.
Our employees are at the core of our success. Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market.

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.

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.