Qualified Person (QP)
Pubblicato il 31-07-2026 - Experteer Italy in Ivrea
ppIn 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. /p ul liflexible and hybrid working options /li li14 weeks paid parental leave /li liinsurance plans /li liglobal recognition programs /li liCertify and release medicinal product batches in compliance with laws and MA conditions /li liEnsure batch documentation is complete, stored securely, and available for inspection /li liAssess and release manufactured products per national legislation and Qualified Person responsibilities /li liCollaborate with Quality Control and Production to support batch-related activities /li liReview, support, and approve deviations,
complaints, change controls, CAPAs, and investigations /li liEscalate significant quality irregularities to site management and AIFA /liliMaintain and continuously improve an effective GMP-compliant Quality Management System /li liIdentify and propose improvements to enhance quality, productivity, and cost efficiency /li liPrevious experience as a Qualified Person within a pharmaceutical sterile manufacturing environment /li liQualification as an Authorized Qualified Person per Legislative Decree No. 219/2006 /li liStrong GMP knowledge and regulatory expectations /li liHigh quality awareness with proactive issue resolution /li liExcellent collaboration and communication across Quality Control, Production, and leadership /li liAbility to support daily production operations while ensuring compliance, safety, and quality /li liFluency in Italian and English (spoken and written) /li /ul /p #J-18808-Ljbffr