Experteer Overview
In this role you will provide QA oversight for Contract Manufacturing Operations, ensuring compliance with company standards and regulatory requirements. You will drive continuous improvement of the Quality Management System and act as a quality partner across the organization to strengthen quality, compliance and operational excellence. You will collaborate with cross-functional teams on GMP issues, technology transfer, regulatory submissions, and incident resolution, shaping robust quality practices in a integral allergy-focused pharmaceutical setting.

Compensaciones / Beneficios
• Perform QA activities for internal Quality Systems (change control, deviations, CAPA, APQR, etc.)
• Review GMP technical and validation reports for manufacturing, packaging, cleaning validation, equipment, facilities and utilities
• Provide QA support to technology transfer projects
• Offer on-site guidance for procedures and work instructions
• Assist in resolving GMP issues via problem area identification, system refinement, and training




• Support regulatory submissions with QA input
• Prepare Material Review Board documentation and meetings
• Support QA Management as required
• Provide GMP quality expertise across the organization as needed

Responsabilidades
• Minimum 5 years in pharmaceutical/biotech with solid knowledge of quality systems, GMP and regulatory requirements
• University degree in Chemistry, Pharmacy, Biology or equivalent
• Fluency in English and Spanish (written and spoken)
• Strong knowledge in oral solid dosage forms and technology transfer
• Knowledge of sterile product regulations is valuable
• Expertise across pharmaceutical sciences, analytical chemistry, microbiology, GMPs, regulatory issues, data integrity
• Strong interpersonal and leadership skills across cultures and in high-pressure situations
• Willingness to travel about 30% of the time

Requisitos principales
• hybrid work model

📌 Senior QA Specialist (Madrid)
🏢 Alk Abello
📍 Madrid