Quality Assurance Specialist

Descripción del empleo

Responsibilities

• Review and approve key GMP documentation generated by the Pharmaceutical Development area, including:
• Manufacturing, packaging, and labeling instructions for IMPs
• Analytical methods, specifications (LIMS), and specification dossiers
• ICH stability protocols and reports
• Method validation documentation
• Shelf-life justification reports for IMPs
• Master Manufacturing Plans
• SOPs related to equipment cleaning, operations, and room procedures
• Qualification protocols and reports for analytical equipment
• Manage and support core Quality activities:
• Deviations, CAPAs, change controls, and complaints
• Investigations of OOS, OOE, OOT, and related CAPA evaluation
• Quality Agreements (creation and maintenance)
• SOPs and controlled documentation for Quality & R&D
• Archiving and GxP documentation management
• Monitor IMP status across the clinical supply chain (manufacturing to end-of-trial)
• Support and participate in internal/external audits and regulatory inspections
• Manage submissions to AEMPS (manufacturing, import/export, controlled substances)

Requirements

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, or a related field
• 3–5 years of QA experience within an R&D or IMP-focused GMP environment
• Strong knowledge of ICH guidelines, GxP, and EU GMP Annex 13
• Experience collaborating with Manufacturing, Analytical, and Regulatory teams
• Fluent Spanish and professional English
• Detail-oriented, proactive, and strong problem-solving mindset
• Team player with the ability to work in cross-functional environments

Información extra

Status

Activa

Estudios requeridos

E.S.O

Localización

Greater Barcelona Metropolitan Area

Tipo de contrato

Trabajo estudiantes

Publicado el

19-04-2026

Carnet de conducir

No

Vehículo

No

Carta de motivación

No

Idiomas

Español