Contract Development and Manufacturing Organization (CDMO) specializing in pharmaceutical and biotechnology products. With a strong presence in Barcelona, we are committed to delivering high-quality solutions in drug development, manufacturing, and regulatory compliance.Job Summary:The QA Specialist will play a critical role in ensuring compliance with GMP (Good Manufacturing Practices), regulatory guidelines, and internal quality systems. This position will support quality operations, batch record review, deviations, CAPAs, audits, and continuous improvement initiatives within a dynamic CDMO environment.Key Responsibilities:Quality Compliance & Documentation:Ensure adherence to GMP, FDA, EMA, and ICH regulatory requirements.Review and approve batch records, SOPs, change controls, deviations, and CAPAs.Maintain and update Quality Management Systems (QMS).Audits & Inspections:Support internal and external audits, including regulatory inspections and client audits.Assist in audit responses and implementation of corrective/preventive actions.Manufacturing & Quality Oversight:Perform in-process quality checks and provide QA support to manufacturing and packaging operations.Monitor and improve Good Documentation Practices (GDP) and compliance standards.Participate in risk assessments and root cause analysis (RCA).Continuous Improvement & Training:Identify areas for quality improvement and drive initiatives for process optimization.Provide GMP training to employees to reinforce a quality-driven culture