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Process Validation QA Specialist

Hybrid in Barcelona·Full-time·Added 11 days ago

Randstad España

6168 open roles

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Overview

Job details

Permanent contract
Full-time hours.
Hybrid
Office and home days — the ad has the split.

Requirements

Have the right to work in Spain
Randstad España doesn't mention sponsorship in the ad.
Work in English
English is required, per the ad.
Be near Barcelona for hybrid days
No relocation package mentioned.
Have 2+ years of experience
Junior-level role.
University degree
“Grado Universitario o Licenciatura en química, ciencias de la salud o afín.” — per the ad.

This job was automatically translated to English.

Pay & benefits

What you'll get

Flexible schedule
1 day of remote work per week

The role

What you'll do

Design, plan, and execute key process validations.
Preparation, review, and updating of protocols and reports.
Develop and review validation protocols and reports for facilities, equipment, and systems (DQ, IQ, OQ, PQ) in accordance with current regulations.
Apply risk analysis methodologies to identify critical points and verify the suitability of process controls and limits.
Execute cleaning validations to minimize cross-contamination.
Ensure that validated processes maintain their performance over time through periodic revalidation activities.

? Manage deviations and non-conformities detected during validation, proposing and executing corrective and preventive actions (CAPA).

Keep validation documentation up to date and participate in internal and external audits related to validations. Evaluate and propose improvements in production processes to increase efficiency without compromising quality.
Development and execution of the Validation Master Plan. Report any deviation from the plan. Collaborate with the Production, Quality, and Maintenance departments to ensure the correct execution of the plans.
Review current procedures and protocols to ensure alignment with GMP Annex 15 regarding validation.
Evaluate new technologies and participate in the validation of new machinery and production systems.
Participate in Quality Management System activities, such as Deviations, Change Controls, CAPAs, etc., specific to the Quality Assurance department.

Requirements

Minimum 2 years of experience in an equal or similar position.
University Degree or Bachelor's in chemistry, health sciences, or a related field.
Knowledge of applicable GMP regulations and ISO for medical devices.
GMP Annex 15 and GAMP5 for the validation of computerized systems.
Desirable knowledge in statistics applied to processes.
Advanced English.
Advanced Microsoft Office user.

Hiring process

2 steps1 interview

Inscripción en la oferta
En revisión · With a consultor/a de Randstad
Preseleccionado
Contacto del consultor/a
With a consultor/a de Randstad
Uno de nuestros consultores revisará tu solicitud y se pondrá en contacto contigo para los siguientes pasos.
Gestión final de la empresa
With an empresa cliente
Randstad actúa como intermediario para conectar candidatos con empresas; en algunos casos la gestión final de los perfiles y la decisión de a quién contactar dependen exclusivamente de la empresa.

Las fases finales las define la empresa cliente: la gestión final de los perfiles y la decisión de a quién contactar dependen exclusivamente de la empresa.
Randstad no publica plazos; el estado de la candidatura puede no cambiar por el alto volumen de inscripciones o porque la empresa gestiona sus propios tiempos.
Los estados publicados llegan solo hasta la preselección: Randstad no detalla entrevistas ni pruebas posteriores.

About Randstad España

Randstad España is the Spanish branch of Randstad N.V., a global leader in human resources and staffing solutions. The company provides a wide range of workforce solutions, including temporary and permanent placement, recruitment process outsourcing, and HR consulting. With a strong presence in Spain, Randstad España connects thousands of professionals with job opportunities across various sectors, including industrial, technical, and customer service roles.

For international professionals, Randstad España offers a gateway to the Spanish job market, with numerous openings in technical maintenance, customer service, and administrative roles. The company values diversity and inclusion, and its extensive network of offices across Spain ensures support for candidates seeking employment in different regions. Randstad's global reach and local expertise make it a reliable partner for those looking to relocate and work in Spain.

Industry: Staffing
Website: randstad.es

In their own words

About the company & team

Our client is a leader in the pharmaceutical sector, distinguished by its track record in the research and development of advanced therapeutic solutions, with a focus deeply rooted in reproductive health and holistic well-being.

All open roles at Randstad España