Quality Assurance Specialist FL-QQ

Kuehne + Nagel AS; Anagni; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A logistics company in Anagni seeks a Quality Assurance Specialist to ensure compliance with European regulatory standards in healthcare products. The role involves managing inspections, documentation for regulatory applications, and addressing customer complaints. The ideal candidate has a Bachelor's degree in relevant fields and at least 3 years of experience in pharmaceutical production, with strong knowledge of GMP standards.

Servizi

Professional growth opportunities

Stable working environment

Focus on well-being

Competenze

• 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.

Mansioni

• Support the Contract Logistics Quality Manager for Healthcare products.
• Ensure compliance with industry standards and European regulatory requirements.
• Manage product inspections and contribute to improvement initiatives.
• Prepare documentation for regulatory bodies.
• Handle customer complaints efficiently.

Conoscenze

Problem-solving skills

Analytical skills

Communication skills

Interpersonal skills

Teamwork

Regulatory knowledge

Formazione

Bachelor's degree in Pharmaceutical chemistry, Pharmacy, Chemistry, Industrial Chemistry, Biological Sciences

Descrizione del lavoro

Overview

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.

Responsibilities

• 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.
• 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\u2019s 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.