02 oct
|
G&L Scientific
|
Cataluña
02 oct
G&L Scientific
Cataluña
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 C
📌 Quality Assurance Manager (Cataluña)
🏢 G&L Scientific
📍 Cataluña