Ambit Iberia is a specialized consulting firm that provides digital transformation and IT services specifically for the Life Sciences, Pharmaceutical, and Healthcare sectors. The company focuses on delivering high-value solutions in areas such as regulatory compliance (GxP), cybersecurity, data engineering, and system validation for major global players in the health industry.

Headquartered in Barcelona, Ambit Iberia offers a dynamic environment for international professionals, particularly those with backgrounds in IT and engineering. The company is known for its flexible work models, including hybrid and fully remote options across Spain, and its international project scope makes it an attractive destination for English-speaking experts looking to enter the Spanish tech-pharma market.

Founded in Barcelona, Ambit has established itself as a reference partner for the regulated industry in Spain. It has expanded its services from IT infrastructure to advanced AI transformation and specialized pharmaceutical system engineering.

QMS & QC Specialist | Pharma (Hybrid)

Ambit Iberia

This job was originally posted in Spanish and automatically translated to English. You'll most likely need Spanish to apply.

Job Description

We are looking for a QMS & QC Specialist to support one of our international clients in the pharmaceutical sector.

In this role, you will actively participate in the management and continuous improvement of quality processes within a highly regulated environment. You will be a key piece in the management of non-conformities, investigations, root cause analysis (RCA), CAPAs, and Change Management, collaborating closely with Quality, Business, and IT teams to ensure compliance with quality and regulatory standards.

TASKS 🚀:

• Manage and support processes for Non-Conformities, Investigations, Root Cause Analysis (RCA), CAPAs, and Change Management.

• Collaborate in the supervision and maintenance of the IT Quality Management System (QMS).

• Prepare and track quality metrics, including KPIs, training compliance, and quality objectives.

• Participate in governance and continuous improvement activities of the Quality Management System.

• Collaborate with Quality, Business, and IT teams in a regulated pharmaceutical sector environment.

• Provide support in activities related to regulatory compliance and internal quality procedures.

• Participate in the preparation, review, and maintenance of quality documentation.

• Collaborate in audits, inspections, and quality reviews when required.

REQUIREMENTS 🤹:

• Demonstrable experience in the management of Non-Conformities, Investigations, Root Cause Analysis (RCA), CAPAs, and Change Management.

• Solid knowledge of Quality Management Systems (QMS) in the pharmaceutical industry.

• Experience working in regulated environments (GxP).

• Familiarity with IT environments, computerized systems, or software products.

• Ability to work cross-functionally with Quality, Business, and IT teams.

• Strong analytical, organizational, and problem-solving skills.

• Native Spanish.

• English level B2 or higher.

OPTIONAL REQUIREMENTS:

• Experience supporting IT Quality Management Systems.

• Knowledge of Computerized System Validation (CSV).

• Experience participating in regulatory audits and inspections.

• Knowledge of pharmaceutical sector quality regulations and standards.

• Experience in international and multicultural environments.

• Proactive profile with good communication and stakeholder management skills.

SCHEDULE 🕘:

Monday to Friday from 08:00 to 17:00
Hybrid model, with on-site presence during onboarding and subsequently a maximum of two days per week.

CONDITIONS 🌱:

Negotiable salary. We will discuss this in our first call
Permanent contract.
Flexible remuneration plan (tax-free), we provide: private health insurance, public transport tickets, and childcare vouchers.
Discounts at the gym network (Urban Sports Club).
Training and development.

Our goal is for you to be well in every sense!

View original advert (Spanish)

Estamos buscando un/a QMS & QC Specialist para dar soporte a uno de nuestros clientes internacionales del sector farmacéutico.

En este rol, participarás activamente en la gestión y mejora continua de los procesos de calidad dentro de un entorno altamente regulado. Serás una pieza clave en la gestión de no conformidades, investigaciones, análisis de causa raíz (RCA), CAPAs y Change Management, colaborando estrechamente con equipos de Calidad, Negocio e IT para garantizar el cumplimiento de los estándares de calidad y regulatorios.

TAREAS 🚀:

• Gestionar y dar soporte a procesos de No Conformidades, Investigaciones, Análisis de Causa Raíz (RCA), CAPAs y Change Management.

• Colaborar en la supervisión y mantenimiento del Sistema de Gestión de Calidad (SGC) de IT.

• Elaborar y dar seguimiento a métricas de calidad, incluyendo KPIs, cumplimiento de formaciones y objetivos de calidad.

• Participar en actividades de gobernanza y mejora continua del Sistema de Gestión de Calidad.

• Colaborar con equipos de Calidad, Negocio e IT en un entorno regulado del sector farmacéutico.

• Dar soporte en actividades relacionadas con el cumplimiento normativo y los procedimientos internos de calidad.

• Participar en la elaboración, revisión y mantenimiento de documentación de calidad.

• Colaborar en auditorías, inspecciones y revisiones de calidad cuando sea requerido.

REQUISITOS 🤹:

• Experiencia demostrable en la gestión de No Conformidades, Investigaciones, Análisis de Causa Raíz (RCA), CAPAs y Change Management.

• Conocimiento sólido de Sistemas de Gestión de Calidad (SGC/QMS) en la industria farmacéutica.

• Experiencia trabajando en entornos regulados (GxP).

• Familiaridad con entornos IT, sistemas computarizados o productos de software.

• Capacidad para trabajar de forma transversal con equipos de Calidad, Negocio e IT.

• Buenas habilidades analíticas, organizativas y de resolución de problemas.

• Castellano nativo.

• Nivel de inglés B2 o superior.

REQUISITOS OPCIONALES:

• Experiencia dando soporte a Sistemas de Gestión de Calidad de IT.

• Conocimientos de Computerized System Validation (CSV).

• Experiencia participando en auditorías e inspecciones regulatorias.

• Conocimiento de normativas y estándares de calidad del sector farmacéutico.

• Experiencia en entornos internacionales y multiculturales.

• Perfil proactivo con buenas habilidades de comunicación y gestión de stakeholders.

HORARIO 🕘:

De lunes a viernes de 08h a 17h
Modalidad híbrida, con presencialidad durante el onboarding y posteriormente un máximo de dos días por semana.

CONDICIONES 🌱:

Salario negociable. Lo comentamos en nuestra primera llamada
Contrato indefinido.
Plan de retribución flexible (libre de IRPF), ponemos a tu disposición: seguro médico privado, billete de transporte público y cheque guardería.
Descuentos en la red de gimnasios (Urban Sports Club).
Formación y desarrollo.