Quality Assurance Specialist

Overview My client is an innovative CDMO based in Barcelona, focused on the development and production of biopharmaceutical products, including novel biologics and biosimilars.

Leveraging advanced technological platforms and a knowledge-driven approach, the company partners closely with its clients to deliver cutting-edge, high-quality solutions.

As part of its strategic expansion, the organization is building a new GMP-compliant manufacturing facility, equipped with state-of-the-art technology to support all phases of biologics production—from development to commercial supply.

The Opportunity

To support this growth, the company is seeking a Quality Assurance Specialist to play a key role in shaping its GMP operations and Quality Management System (QMS).

Ideal Candidate Profile

Bachelor's degree in Pharmacy (or related life sciences discipline).

5+ years of experience in GMP Quality Assurance roles within the biopharmaceutical industry.

Strong expertise in Quality Management Systems, including deviations, CAPA, change controls, audits, and supplier qualification.

Experience with qualification of facilities, utilities, and equipment.

Knowledge of batch release processes and eligibility to act as QP deputy under Real Decreto 824 / 2010.

Strong problem-solving and decision-making capabilities.

Fluency in Spanish and English, with excellent communication, organization, and team collaboration skills.

Key Responsibilities

Support the design, implementation, and maintenance of a robust QMS for GMP manufacturing activities.

Author, review, and approve Standard Operating Procedures (SOPs).

Lead the Documentation Management System, including training coordination.

Oversee facility, utility, and equipment qualification, including protocol and report approval, and related change control activities.

Lead the supplier qualification program, including onboarding and performance monitoring.

Review Technical Agreements with suppliers and clients.

Support batch documentation review in preparation for product release.

What's on Offer

An opportunity to be a foundational part of a new GMP facility, contributing to QMS creation from the ground up.

Involvement in the development of diverse biological products, offering end-to-end exposure to the biopharmaceutical lifecycle.

A flexible work schedule aligned with production processes and project needs.

A collaborative, innovation-driven environment with strong growth prospects.

This is a rare opportunity for an experienced Quality Assurance professional to join a forward-thinking organization on the frontline of biopharmaceutical innovation.