Qualified Person
Pubblicato il 13-08-2026 - Altro in Ivrea
In this role you will oversee manufacturing and quality control activities at the Ivrea site to ensure compliance with GMP, regulatory licensing, and local laws. You will work with Site Quality Head and Site Manager to implement and maintain a GMP-driven Quality Management System. You will certify batch releases, review deviations and CAPAs, and elevate issues to authorities when needed. This position offers operational and strategic influence to uphold quality, safety, and regulatory standards within a collaborative environment. flexible and hybrid working options
14 weeks paid parental leave
insurance plans
global recognition programs
Certify and release medicinal product batches in compliance with laws and MA conditions
Ensure batch documentation is complete, stored securely, and available for inspection
Assess and release manufactured products per national legislation and Qualified Person responsibilities
Collaborate with Quality Control and Production to support batch-related activities
Review, support, and approve deviations,
complaints, change controls, CAPAs, and investigations
Escalate significant quality irregularities to site management and AIFA
Maintain and continuously improve an effective GMP-compliant Quality Management System
Identify and propose improvements to enhance quality, productivity, and cost efficiency
Previous experience as a Qualified Person within a pharmaceutical sterile manufacturing environment
Qualification as an Authorized Qualified Person per Legislative Decree No. 219/2006
Strong GMP knowledge and regulatory expectations
High quality awareness with proactive issue resolution
Excellent collaboration and communication across Quality Control, Production, and leadership
Ability to support daily production operations while ensuring compliance, safety, and quality
Fluency in Italian and English (spoken and written)
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