Quality Compliance Lead: Deviation, CAPA & Change Control

G&L Scientific; Barcelona; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

G&L Scientific is seeking an experienced Deviation, CAPA & Change Control Specialist to support Quality and Compliance activities within a regulated GxP environment. The role involves owning deviation and CAPA management and supporting change controls and related compliance tasks.

The successful candidate will manage investigations, perform root-cause analysis, implement corrective actions, and ensure documentation and processes meet GMP/GxP requirements.

Formación

• Proven experience in Deviation Management, CAPA and Change Control in 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.
• Expertise in root-cause analysis and investigation methodologies.

Responsabilidades

• Act as owner for minor and major deviations, from initiation through closure.
• Lead deviation investigations with impact assessments and root-cause analysis.
• Manage CAPAs, ensuring defined actions are implemented and closed on time.
• Monitor CAPA effectiveness and prevent recurrence.
• Support management of Change Controls, including impact assessment and closure.
• Collaborate with cross-functional stakeholders to implement deviations, CAPAs and changes.
• Ensure quality records are complete, traceable and inspection-ready.
• Support audit and inspection readiness activities.
• Provide guidance on deviation, CAPA and change control processes.

Conocimientos

Deviation management

CAPA

Change control

Quality management systems

GxP compliance

Descripción del empleo

G&L Scientific is seeking an experienced Deviation, CAPA & Change Control Specialist to support Quality and Compliance activities within a regulated GxP environment. The role involves owning deviation and CAPA management and supporting change controls and related compliance tasks.

The successful candidate will manage investigations, perform root-cause analysis, implement corrective actions, and ensure documentation and processes meet GMP/GxP requirements.