QA Officer

Novartis

Industria farmacéutica

Zaragoza, Aragón - Spanien

Project Manager Sénior / Especialista sénior

Experteer Overview

As QA Officer you ensure quality oversight across GMP activities at the facility, safeguarding product integrity from production to shipment. You will collaborate with QA peers to validate site equipment, train personnel, and manage quality documentation. You oversee provisional batch release and ensure batch records are closed in a timely manner, while maintaining compliance with GMPs and Health Authority requirements. You work cross-functionally to support audits, site documentation, and investigations, shaping a robust local quality system. This role offers the chance to impact manufacturing quality at scale and contribute to patient safety and regulatory readiness.

Responsabilidades

Supervise hygiene and GMP conditions across the premises
Contribute to validation/qualification of site, equipment, and training
Oversee provisional batch release for shipments
Work in shifts with other QA officers to supervise production and QA activities
Archive and manage GMP documentation; review batch records and ensure timely closure
Maintain and ensure compliance of the local quality system with GMPs and regulations
Support QP in preparing batch release documents
Assist in redaction and printing of batch documentation
Support external and corporate audits
Compile data for Product Reviews and monitor investigations and corrective actions
Participate in self-inspections and external audits as per plan
Ensure quality oversight during GMP activities across manufacturing, QC, distribution, and processes