Qualification Engineer
4 settimane fa
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, utilities, and computerized systems, and collaborating with cross-functional teams to develop validation master plans and standard operating procedures.
Key Activities- Develop and implement equipment and utilities qualification plans to ensure compliance with regulatory requirements.
- Lead qualification activities for new or modified equipment, utilities, and computerized systems, ensuring timely and efficient execution.
- Collaborate with suppliers to ensure qualification activities are completed in accordance with regulatory requirements.
- Supervise temperature mapping activities for equipment, warehouses, and climatic chambers.
- Contribute to the development of validation master plans, standard operating procedures, and other GMP documents.
- Participate in internal or external training programs to maintain knowledge of qualification principles, industry trends, and best technologies.
- 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.
We offer a dynamic and inclusive work environment, with opportunities for professional growth and development. Our benefits package includes a canteen, working flexibility, coffee key, recognition program, welfare platform, health agreement, and access to LinkedIn Learning.
Location and Working ProgramThis role is based in Rho (MI), with a working program from Monday to Friday.
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