Senior Qualified Person (QP) – EU/Global Certification

Bristol-Myers Squibb

Dublin

Híbrido

EUR 120.000 - 150.000

Jornada completa

Hace 6 días

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Descripción de la vacante

Bristol Myers Squibb in Ireland is seeking an experienced Senior Manager, Qualified Person to join our Pharma QP Operations on a 12-month fixed-term contract. As a named EU Qualified Person, you will certify pharmaceutical products for EU/EEA and global markets in compliance with GMP.

You will collaborate with internal sites, external manufacturers, regulatory affairs and quality teams to ensure uninterrupted supply of compliant medicines to patients, support product launches and drive

Formación

EU/EEA QP eligibility meeting the educational requirements of Article 49 of Directive 2001/83/EC.
MSc (or equivalent) in a scientific, technical or related discipline.

Responsabilidades

Perform EU Qualified Person duties for EU/EEA and global markets in accordance with GMP and regulatory requirements.
Provide expert guidance to Quality Operations teams supporting batch certification activities.
Support investigations through FIT, FIRM and Product Review Committee processes.
Partner with launch excellence, supply chain and manufacturing teams to support new product introductions and market launches.
Participate in regulatory inspections and regulatory notifications, recalls and audits.
Maintain current knowledge of GMP and regulatory requirements through ongoing professional development.