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)

#J-18808-Ljbffr

📌 Qualified Person (QP) (Ivrea)
🏢 Experteer Italy
📍 Ivrea