OverviewIn this role you will ensure commercial medicinal products meet manufacturing, testing, and distribution requirements under current legislation and internal procedures.
You will review samples and documentation and manage release for distribution, operating within a cross-functional quality environment.
You will support GxP compliance and the Quality Management System, contributing to safe and compliant product supply.
This position offers exposure to EU regulatory activities and batch certification processes in a general pharma setting.
Compensaciones / Beneficiosinsurance plans
retirement plans
wellbeing resources
global recognition programs
flexible and hybrid working options
minimum of 14 weeks paid parental leave
ResponsabilidadesPerform batch documentation review prior to release by the QP
Initiate and obtain the EU Batch Certificate for centrally authorized products
Assess transport of products and evaluate temperature excursions




Manage urgent requests and releases
Manage reconditioning of commercial batches in line with GMPs
Ensure implementation of SLC with Supply, DRA, and related departments
Report monthly indicators and maintain documentation and sample archives
Review samples and related documentation
Ensure overall GxP compliance and compliance with Novartis Quality Management Systems
Requisitos principales1+ years of experience in Quality Assurance and/or Quality Control
Strong knowledge of GMPs and pharmaceutical manufacturing processes
Native Spanish and good level of English
GMP knowledge
Quality Assurance/Quality Control
Batch documentation review
Release for distribution processes
EU Batch Certificate initiation and handling
SLC implementation collaboration with Supply, DRA, and other departments

📌 Quality Assurance Release Officer (España)
🏢 Novartis
📍 España