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Qualification Engineer

2 mesi fa

Rho, Lombardia, Italia Teva Pharmaceuticals A tempo pieno
About the Role

We are seeking a highly skilled Qualification Engineer to join our Engineering Department. As a key member of our team, you will be responsible for defining and managing the equipment and utilities requalification plan, leading the qualification of new or modified equipment, and collaborating with cross-functional teams to develop validation master plans and standard operating procedures.

Main Responsibilities
  • Develop and implement equipment and utilities qualification plans to ensure compliance with regulatory requirements.
  • Lead the qualification of new or modified equipment, utilities, and computerized systems to ensure their safe and effective operation.
  • Collaborate with the Engineering team and other departments to develop validation master plans, standard operating procedures, and other GMP documents.
  • Analyze and conduct risk assessments to support Engineering projects and Maintenance activities.
  • Support the Maintenance Manager in reviewing the preventive maintenance plan based on equipment qualification results.
Requirements
  • Strong knowledge of Quality Management Systems, including GMP, GDP, and Data Integrity.
  • Experience with equipment and utilities qualification best practices.
  • Knowledge of Environment, Health, and Safety principles and applicable local regulations.
  • Excellent communication and collaboration skills.
  • Fluency in English and Italian.
What We Offer

We offer a dynamic and inclusive work environment, with opportunities for professional growth and development. Our benefits package includes a competitive salary, comprehensive health insurance, and access to LinkedIn Learning for continuous learning and development.

We are committed to equal opportunities in the workplace and welcome applications from diverse candidates.