Quality Assurance Specialist

Actual Talent Spain; Ceuta; Presencial; EUR 30.000 - 55.000; Jornada completa

Descripción de la vacante

Una consultora de adquisición de talento busca un Especialista en QA estratégico que supervise y eleve los estándares de calidad de su red de fabricación externa. El candidato ideal tendrá de 2 a 5 años de experiencia en Aseguramiento de Calidad, conocimientos en regulaciones GMP y habilidades técnicas en SAP y LIMS. Se requiere dominio del inglés y español, así como disponibilidad para viajes ocasionales. Esta es una gran oportunidad para impactar la seguridad y cumplimiento de productos medicinales.

Formación

• 2-5 años de experiencia progresiva en un departamento de Aseguramiento de Calidad en el sector farmacéutico.
• Dominio de regulaciones GMP/GDP y Sistemas de Gestión de Calidad.
• Disponibilidad para viajar ocasionalmente para auditorías.

Responsabilidades

• Actuar como el líder de calidad para moléculas y formas de dosificación terminadas.
• Gestionar y rastrear los procesos clave de QMS.
• Autorización y aprobación de documentos críticos como MBR y SOPs.
• Dirigir o revisar estrategias de validación y cualificación.
• Realizar auditorías externas de proveedores y CMOs.

Conocimientos

Mentalidad analítica excepcional

Capacidad para trabajar bajo presión

Actitud proactiva hacia el cambio

Gestión de proyectos

Habilidades en idiomas (inglés y español)

Educación

Título en Ciencias de la Vida (Farmacia, Química, Biología) o Ingeniería

Máster en la Industria Farmacéutica

Herramientas

SAP

LIMS

Microsoft Office Suite

Descripción del empleo

Overview

Actual Talent is the talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions.

¡Inscríbase sin demora! Se espera un gran volumen de solicitantes para el puesto que se detalla a continuación, no espere para enviar su CV.

Our purpose is to drive the growth and fulfillment of individuals and organizations.

We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level.

We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology.

Our client is looking for a strategic QA Specialist to oversee and elevate the quality standards of their external manufacturing network.

In this role, you will be the primary Quality point of contact for Contract Manufacturing Organizations (CMOs), ensuring that every drug product is manufactured, tested, and released in total alignment with GMP, GDP, and ICH guidelines.

Your work will directly impact the safety and compliance of medicinal products throughout their entire lifecycle.

Responsibilities

• Product Stewardship: Act as the Quality Lead for assigned molecules and finished dosage forms (FDFs), overseeing lifecycle changes, API source updates, and manufacturing process optimizations at external sites.
• Quality Systems Oversight: Manage and track core QMS processes, including Deviations, Corrective and Preventive Actions (CAPAs), Out of Specification (OOS) investigations, and Change Control management.
• Technical Documentation: Author, evaluate, and approve critical documents such as Master Batch Records (MBR), Quality Agreements, SOPs, Analytical Methods, and Regulatory Filing dossiers.
• Validation & Qualification: Lead or review validation strategies (process, cleaning, and transport) and the qualification of facilities, utilities, and equipment.
• Audits & Compliance: Conduct external audits of suppliers and CMOs.
• Represent the quality department during Health Authority inspections and third-party audits.
• Performance Monitoring: Drive the preparation of Product Quality Reviews (PQR) and implement continuous improvement initiatives based on CMO performance data.
• Technical Support: Provide expert quality guidance for marketed products and lead GMP training sessions for internal teams and partners.

Qualifications

• Academic Background: University degree in Life Sciences (Pharmacy, Chemistry, Biology) or Engineering.
• A Master’s degree in the Pharmaceutical Industry is highly preferred.
• Professional Experience: At least 2–5 years of progressive experience within a Quality Assurance department in the pharma sector.
• Regulatory Expertise: Strong command of GMP/GDP regulations and Quality Management Systems.
• Technical Tools: Proficiency in SAP, LIMS, and Microsoft Office Suite.
• Soft Skills: Exceptional analytical mindset, ability to work under pressure, and a proactive attitude toward change and project management.
• Languages: Full professional proficiency in both English and Spanish.
• Availability: Willingness to travel occasionally for audits and professional development.