Quality Assurance Specialist
1 settimana fa
It's more than a job In an administrative role at Kuehne+Nagel, tasks such as managing office operations or coordinating schedules certainly contribute to your team's success, but they also provide meaningful moments for people around the world. Because your attention to detail supports your colleagues to perform at their best, such as ensuring the timely and seamless transport of hearing aids and advanced medical devices that change lives. At Kuehne+Nagel, our work contributes to more than we imagine. The Quality Assurance Specialist supports the Contract Logistics Quality Manager for Healthcare products, focusing on the implementation and maintenance of quality processes within our contract logistics operations. The role involves ensuring compliance with industry standards and European regulatory requirements, managing product inspections, and contributing to continuous improvement initiatives. How you create impact Support the implementation and maintenance of a quality management system compliant with current site authorizations and national legislation requirements for certain products. Aid in the preparation of documentation for AIFA (Italian Medicines Agency) and other regulatory bodies for new applications. Assist in the management of psychotropic drugs according to D.P.R. 309/90 and its amendments, ensuring the availability of Import/Export permits and timely notifications to the Ministry of Health. Manage the process for returned, rejected, recalled, or falsified products. Address customer complaints efficiently to ensure satisfactory resolutions. Support the qualification of suppliers, systems, and equipment. Assist in managing training and audit programs to ensure staff compliance with current standards. Support the identification, investigation, and reporting of compliance issues, irregularities, and violations. Aid in the implementation and management of CAPA (Corrective and Preventive Actions) plans Ensure temperature monitoring of warehouse and critical systems comply with GXP standards. What we would like you to bring Bachelor's degree in Pharmaceutical chemistry, Pharmacy, Chemistry, Industrial Chemistry, Biological Sciences. 3 years of experience in pharmaceutical production or a similar role. Eligibility to be certified as a Qualified Person. Strong knowledge of GMP and regulatory requirements. Excellent problem-solving and analytical skills. Ability to work effectively in a team environment. Strong communication and interpersonal skills. Proficiency in English and Italian. What's in it for you By joining the Kuehne+Nagel team, you will have the opportunity to work in a safe and stable environment, with a strong focus on physical and mental well-being. We offer professional growth and development opportunities, including at an international level. Who are we Logistics shapes everyday life - from the goods we consume to the healthcare we rely on. At Kuehne+Nagel, your work goes beyond logistics; it enables both ordinary and special moments in the lives of people around the world. As a global leader with a strong heritage and a vision to move the world forward, we offer a safe, stable environment where your career can make a real difference. Whether we help deliver life-saving medicines, develop sustainable transportation solutions or support our local communities, your career will contribute to more than you can imagine. We kindly advise that placement agencies refrain from submitting unsolicited profiles. Any submissions of candidates without prior signed agreement will be considered our property and no fees will be paid.
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Quality Assurance Specialist
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