On-Site QA Specialist Madrid — GMP & Batch Release

PQE Group; Madrid; Presencial; EUR 40.000 - 52.000; Jornada completa

Descripción de la vacante

PQE Group is seeking an experienced Quality Assurance Specialist in Spain, primarily based in Madrid. The role focuses on batch release, GMP compliance, quality systems management, supplier oversight, audits, and continuous improvement to ensure product quality and regulatory compliance.

The position is on-site in Azuqueca de Henares (Madrid) for the project duration. You will develop and manage SOPs, CAPAs, change controls, and training, supporting audits and interactions with suppliers and

Formación

• Experience in QA within pharmaceutical or medical device sectors.
• Knowledge of GMP and regulatory requirements.
• Ability to manage deviations, investigations, and CAPAs.

Responsabilidades

• Review/approve specifications for APIs, raw materials, packaging, bulk and finished products.
• Review batch records and release documentation for GMP compliance.
• Approve or reject batches in SAP based on disposition.
• Issue Certificates of Analysis (CoA) for regulatory purposes.
• Monitor deviations, OOS/OOT investigations, and quality events.

Conocimientos

GMP compliance

Quality assurance

Batch release

SOP development

CAPA management

Herramientas

SAP

Document control system

Descripción del empleo

PQE Group is seeking an experienced Quality Assurance Specialist in Spain, primarily based in Madrid. The role focuses on batch release, GMP compliance, quality systems management, supplier oversight, audits, and continuous improvement to ensure product quality and regulatory compliance.

The position is on-site in Azuqueca de Henares (Madrid) for the project duration. You will develop and manage SOPs, CAPAs, change controls, and training, supporting audits and interactions with suppliers and