GMP QA Specialist — Compliance & CAPA Lead

Chemo; León; Presencial; EUR 42.000 - 63.000; Jornada completa

Descripción de la vacante

Laboratorios Leon Farma / Farmalan in Spain seeks a Quality Assurance professional to assure GMP, regulatory and internal standards. You will oversee complaints, CAPAs, returns, recalls, and site service compliance with internal procedures, GMPs, authorities and customer requirements. The role also involves SOP development, investigations, audits support, and maintaining GMP documentation and archives. Excellent organization, communication, and problem-solving are essential.

Formación

• Degree in Pharmacy, Chemistry or Sciences.
• English at intermediate or high level; Spanish bilingual.
• At least 3 years' experience in a similar QA/regulatory role.
• Knowledge of EU and US GMPs and CAPA systems (Complaints).

Responsabilidades

• Develop and maintain standard operating procedures to ensure regulatory compliance.
• Manage complaints, CAPAs, returns and recalls per procedures.
• Coordinate investigations with departments and identify root causes.
• Support external audits and inspections and assist the Qualified Person.
• Maintain GMP documentation and archives.

Conocimientos

Good communication

Proactivity

Problem solving

Organizational skills

Educación

Degree in Pharmacy or Chemistry or Sciences

Herramientas

SAP Management

Trackwise

Office suite

Descripción del empleo

Laboratorios Leon Farma / Farmalan in Spain seeks a Quality Assurance professional to assure GMP, regulatory and internal standards. You will oversee complaints, CAPAs, returns, recalls, and site service compliance with internal procedures, GMPs, authorities and customer requirements. The role also involves SOP development, investigations, audits support, and maintaining GMP documentation and archives. Excellent organization, communication, and problem-solving are essential.