Overview

In 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 global pharma setting.

Compensaciones / Beneficios

- insurance plans
- retirement plans
- wellbeing resources
- general recognition programs
- flexible and hybrid working options
- minimum of 14 weeks paid parental leave

Responsabilidades

- Perform 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 principales

- 1+ 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 (Barcelona)
🏢 Novartis
📍 Barcelona