We are seeking an experienced Deviation, CAPA & Change Control Specialist to support Quality and Compliance activities within a regulated GxP environment.

The successful candidate will take ownership of deviation and CAPA management while supporting the effective assessment and implementation of change controls and other compliance-related activities.

The role requires strong expertise in pharmaceutical/biotech quality systems, with a proven ability to manage investigations, identify root causes, implement effective corrective and preventive actions, and ensure compliance with applicable procedures and regulatory requirements.

Key Responsibilities * Act as the owner for minor and major deviations, ensuring timely and compliant management from initiation through closure. * Lead and/or coordinate deviation investigations, including impact assessments, root-cause analysis and identification of appropriate corrective actions. * Manage CAPAs, ensuring actions are appropriately defined, implemented, documented and closed within agreed timelines. * Monitor CAPA effectiveness and ensure actions address the identified root cause and prevent recurrence. * Support the management of Change Controls, including impact assessment, documentation, implementation and closure. * Collaborate with cross-functional stakeholders to ensure deviations, CAPAs and changes are effectively assessed and implemented.



* Provide support for Quality and Compliance activities, ensuring adherence to internal procedures and applicable GxP requirements. * Ensure quality records and documentation are complete, accurate, traceable and inspection-ready. * Identify recurring issues and trends and contribute to continuous improvement of the Quality Management System. * Support audit and inspection readiness activities as required. * Provide expert guidance and advice on deviation, CAPA and change control processes.

Required Experience & Expertise * Proven experience in Deviation Management, CAPA and Change Control within a regulated GxP environment. * Strong knowledge of pharmaceutical/biotech Quality Management Systems (QMS). * Experience managing both minor and major deviations from initiation through final closure. * Demonstrated expertise in root-cause analysis and investigation methodologies. * Experience developing, managing and assessing the effectiveness of CAPAs. * Good understanding of GMP/GxP regulations and compliance requirements. * Strong stakeholder management and cross-functional collaboration skills. * Excellent organisational skills, with the ability to manage multiple quality activities and deadlines. * Strong written and verbal communication skills. * Ability to work independently, take ownership and drive quality issues through to successful resolution.

📌 Quality Assurance Manager (España)
🏢 G Scientific
📍 España