QA Specialist (PRD) – Investigations, CRs, CAPAs & Floor Oversight

Chemo; León; Presencial; EUR 45.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Career progression and development

Ongoing training

Subsidised canteen and employee benefits

Descripción de la vacante

Chemo is seeking a QA Specialist in León, Spain, with a passion for quality assurance in the pharmaceutical industry. This role involves leading investigations, managing change controls, and providing real-time QA support in a GMP-regulated environment. Candidates should have at least 3 years of experience in quality roles and a strong understanding of production-related quality activities. The position offers career progression, ongoing training, and a supportive workplace culture.

Formación

• At least 3 years’ experience in similar roles within the Quality department in pharmaceutical industrial settings.
• Strong exposure to production-related quality activities in GMP-regulated environments.

Responsabilidades

• Lead and manage quality investigations related to production activities.
• Perform root cause analysis and documentation of findings.
• Review and approve change requests/change controls.
• Provide routine QA floor oversight and support production teams.

Conocimientos

Quality Assurance in GMP environments

Root cause analysis

Leadership

Compliance and integrity

Descripción del empleo

Experience: At least 3 years’ experience in similar roles within the Quality department in pharmaceutical industrial settings

Position Overview

We are looking for a QA Specialist (PRD) – Investigations, CRs, CAPAs & Floor Oversight who is passionate about the industrialisation of new products.

General Responsibilities

Ensure quality oversight of production-related activities in a GMP-regulated manufacturing environment, acting as a key quality partner for operations on the shop floor. The role is responsible for leading and coordinating investigations, change controls and CAPAs, ensuring appropriate risk assessment, impact evaluation and timely closure in compliance with quality and regulatory requirements. In addition, the position provides real-time QA support to production, reinforcing GMP compliance, issue resolution and continuous improvement across daily manufacturing operations.

Specific Responsibilities

• Lead and manage quality investigations related to deviations associated with production activities.
• Perform and support root cause analysis, ensuring robust identification of underlying causes and appropriate documentation of findings.
• Evaluate the impact of deviations on product quality, manufacturing processes and GMP/regulatory compliance.
• Coordinate cross-functional investigation activities with Production, Engineering, Quality Control, Maintenance and other relevant departments.
• Review, assess and approve change requests/change controls, ensuring proper justification, impact assessment and implementation in line with GMP requirements.
• Ensure that change controls are adequately evaluated, approved, implemented and closed within established timelines.
• Review and approve CAPA plans derived from investigations, audits and inspections, ensuring actions are appropriate and sustainable.
• Monitor CAPA implementation and verify effectiveness prior to closure.Provide routine QA floor oversight through regular presence in production areas, supporting real-time decision-making and compliance with approved procedures.
• Support production teams during critical operations, helping resolve GMP issues promptly and reinforcing quality culture on the shop floor.

Experience (Area)

Quality Assurance in GMP-regulated pharmaceutical or biotechnology manufacturing environments, with strong exposure to production-related quality activities.

Personal Skills

• Adaptability to change and flexibility
• Speed without compromising on quality
• Leadership and teamwork
• Compliance, integrity and sustainability

Benefits

• Career progression and development within a growing international group
• Ongoing training and an innovative working environment
• Subsidised canteen and other employee benefits

Equal Opportunity

Commitment to equal opportunities at LEONFARMA, we believe in and act to promote genuine equality of opportunity. We do not discriminate on the basis of gender, ethnicity, religion, sexual orientation, disability or any other characteristic. We value diversity and talent.