Quality Assurance Manager

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

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.