Deviation, CAPA & Change Control Lead

G&L Scientific; Barcelona; Presencial; EUR 52.000 - 76.000; Jornada completa

Descripción de la vacante

G&L Scientific is seeking an experienced Deviation, CAPA & Change Control Specialist to support Quality and Compliance in a regulated GxP environment. You will own deviation and CAPA management and assist with change controls and related activities.

You will investigate deviations, perform root-cause analysis, define corrective actions, monitor effectiveness, and ensure documentation and inspection readiness.

Formación

• Proven experience in Deviation Management, CAPA and Change Control within a regulated GxP environment.
• Strong knowledge of Quality Management Systems (QMS) in pharma/biotech.
• Experience managing both minor and major deviations from initiation through closure.
• Expertise in root-cause analysis and investigation methodologies.
• Experience developing and assessing CAPA effectiveness.
• Knowledge of GMP/GxP regulations and compliance requirements.

Responsabilidades

• Act as the owner for deviations, ensuring timely and compliant management from initiation through closure.
• Lead deviation investigations with impact assessments, root-cause analysis and corrective actions.
• Manage CAPAs, ensuring actions are defined, implemented, and closed within timelines.
• Monitor CAPA effectiveness and address root causes to prevent recurrence.
• Support management of Change Controls, including impact assessment and closure.
• Collaborate with stakeholders to ensure deviations, CAPAs and changes are properly implemented.
• Provide guidance on deviation, CAPA and change control processes.

Conocimientos

Deviation management

CAPA

Change control

QMS

Root-cause analysis

GxP compliance

Cross-functional collaboration

Documentation

Audit readiness

Independent ownership

Descripción del empleo

G&L Scientific is seeking an experienced Deviation, CAPA & Change Control Specialist to support Quality and Compliance in a regulated GxP environment. You will own deviation and CAPA management and assist with change controls and related activities.

You will investigate deviations, perform root-cause analysis, define corrective actions, monitor effectiveness, and ensure documentation and inspection readiness.