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.#J-18808-Ljbffr

📌 Quality Assurance Manager (Lérida)
🏢 G&L Scientific
📍 Lérida