Quality Specialist (Documentation)

Hlx Life Sciences; Gerona; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

Hlx Life Sciences in Catalonia, Spain, is seeking a skilled professional to manage pharmaceutical documentation within GMP environments. This role blends on-site collaboration with flexible remote work, focusing on documentation integrity and lifecycle management.

The ideal candidate will have a strong understanding of GMP environments and relevant documentation experience, offering significant growth opportunities as the company expands internationally.

Formación

• Strong understanding of GMP environments.
• Experience with controlled quality documentation systems.
• Familiarity with analytical methods and regulatory documentation.

Responsabilidades

• Managing and maintaining GMP-controlled documentation and records.
• Supporting product registrations across multiple countries.
• Ensuring compliance with GMP and pharmacopoeia requirements.

Conocimientos

Understanding of GMP environments

Experience with controlled quality documentation systems

Familiarity with analytical methods and regulatory documentation

Strong Microsoft Office skills

Structured documentation skills

Educación

Scientific or technical academic background

Descripción del empleo

We’re supporting a well‑established biologics pharmaceutical organization based in Catalonia, Spain, currently undergoing a significant expansion across its manufacturing and quality operations.

This position offers a strong mix of on‑site collaboration (typically 3‑4 days per week) with flexible remote working, and sit within highly regulated GMP environments across both manufacturing and corporate quality functions.

This role focuses on ensuring the integrity, control, and lifecycle management of regulated pharmaceutical documentation across global markets.

Key responsibilities:

• Managing and maintaining GMP‑controlled documentation and records
• Supporting product registrations across multiple countries
• Maintaining specifications, analytical methods, SOPs, and change controls
• Ensuring compliance with GMP and pharmacopoeia requirements
• Working closely with Quality Control and Regulatory Affairs teams

What we’re looking for:

• Strong understanding of GMP environments
• Experience with controlled quality documentation systems
• Familiarity with analytical methods and regulatory documentation
• Strong Microsoft Office and structured documentation skills
• Scientific or technical academic background

This role offers the chance to join a growing international organization at a pivotal stage of expansion, with strong development opportunities across quality, validation, and corporate systems.