Quality Assurance Officer
Novartis
Industria farmacéutica
Zaragoza, Aragón - Spanien
Project Manager Sénior / Especialista sénior
Experteer Overview
In this role, you ensure comprehensive quality oversight across GMP activities at the facility. You work within the Quality team to supervise hygiene, validate site readiness, manage quality documentation, and authorize provisional batch release. You collaborate on audits, self-inspections, and data reviews, helping to maintain compliance with GMPs and health authority requirements. You will engage cross-functionally to support batch documentation and quality systems, contributing to reliable product quality and timely releases. This is a hands-on position in a mission-driven company focused on delivering high-quality medicines.
Responsabilidades
- Oversee hygiene and general site conditions
- Contribute to validation/qualification of site, equipment, and personnel training
- Manage provisional batch release for shipments
- Coordinate with QA officers to supervise production and QC activities
- Archive and manage GMP documentation, review batch records, ensure timely closure
- Maintain local quality system in line with GMPs and corporate guidelines
- Support QP in preparing batch release documents
- Contribute to redaction and printing of GMP documentation
- Assist during external and corporate audits
- Support data compilation for Product Reviews and oversee investigations with corrective actions
- Participate in self-inspections and external audits according to the annual plan
- Ensure quality oversight during GMP activities across manufacturing, QC, distribution and quality processes
Requisitos principales
- Education: Scientific degree in Pharmacy, Chemistry or Biology
- 1+ years of experience in a Quality department
- Strong affinity with quality issues
- Good organizational skills with attention to detail
- Solid knowledge of GMP quality systems and basic regulatory requirements
- Fluent English written and spoken
Descripción del puesto
In this role, you ensure comprehensive quality oversight across GMP activities at the facility. You work within the Quality team to supervis…
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