Quality Assurance Lead: Deviation, CAPA & Change Control

G&L Scientific; Cataluña; Presencial; EUR 55.000 - 75.000; 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. You will own deviation and CAPA management while collaborating on change controls and other compliance tasks.

The role requires deep knowledge of pharmaceutical/biotech quality systems, ability to manage investigations, identify root causes, implement corrective actions, and ensure compliance with procedures and regulatory

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 minor and major deviations from initiation through final closure.
• Expertise in root-cause analysis and investigation methodologies.
• Experience developing, managing and assessing CAPA effectiveness.
• Good understanding of GMP/GxP regulations and compliance requirements.

Responsabilidades

• Act as owner for minor and major deviations, ensuring timely and compliant management from initiation through closure.
• Lead and coordinate deviation investigations, including impact assessments, root-cause analysis and corrective actions.
• Manage CAPAs, ensuring actions are defined, implemented, documented and closed within timelines.
• Monitor CAPA effectiveness and ensure actions address root causes and prevent recurrence.
• Support management of Change Controls, including impact assessment and closure.
• Collaborate with cross-functional stakeholders to assess and implement deviations, CAPAs and changes.
• Provide support for Quality and Compliance activities, ensuring adherence to procedures and GxP requirements.
• Ensure quality records and documentation are complete, traceable and inspection-ready.
• Identify recurring issues and contribute to continuous improvement of the Quality Management System.
• Support audit and inspection readiness activities as required.
• Provide expert guidance on deviation, CAPA and change control processes.

Conocimientos

Deviation Management

CAPA

Change Control

Quality Management Systems

GxP Compliance

Root-Cause Analysis

Investigations

Stakeholder Management

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. You will own deviation and CAPA management while collaborating on change controls and other compliance tasks.

The role requires deep knowledge of pharmaceutical/biotech quality systems, ability to manage investigations, identify root causes, implement corrective actions, and ensure compliance with procedures and regulatory