QA & QC Specialist for GMP & Analytics

Roxall Medicina España; País Vasco; Presencial; EUR 32.000 - 42.000; Jornada completa

Descripción de la vacante

Roxall Medicina España is seeking a Quality Assurance Technician with strong QA/QC expertise to ensure compliance with the company’s QMS and GMP, GDP, regulatory and legal requirements. You will focus on quality control activities, analytical results, and method validation.

The role reports to the Head of the Quality Assurance Unit within the Technical Directorate, contributing to continuous improvement and collaboration across QA, QC, R&D and other technical areas.

Formación

• University degree in Biochemistry, Biotechnology, Pharmacy, Chemistry or related discipline.
• Minimum 2 years’ experience in a GMP-regulated pharmaceutical laboratory.
• Experience with review of analytical results and OOS investigations.
• Experience with analytical method validation and GMP documentation.
• Knowledge of EU GMP requirements and ICH Guidelines.
• Fluent English (written and spoken, C1 level).

Responsabilidades

• Prepare, review or supervise QMS procedures and documentation for Quality Control.
• Review analytical results and participate in investigations of deviations and CAPAs.
• Contribute to Product Quality Reviews (PQRs) and Change Controls.
• Provide QA oversight of analytical method validation activities and reports.
• Collaborate on validation activities for manufacturing processes and cleaning procedures.
• Train personnel on Quality Management and GMP requirements.

Conocimientos

GMP experience

Analytical method validation

OOS investigations

CAPA & Change Controls

Data Integrity

English proficiency (C1)

Educación

Biochemistry/Biotechnology/Pharmacy/Chemistry degree

Descripción del empleo

Roxall Medicina España is seeking a Quality Assurance Technician with strong QA/QC expertise to ensure compliance with the company’s QMS and GMP, GDP, regulatory and legal requirements. You will focus on quality control activities, analytical results, and method validation.

The role reports to the Head of the Quality Assurance Unit within the Technical Directorate, contributing to continuous improvement and collaboration across QA, QC, R&D and other technical areas.