Position: QA Specialist (PRD) – Investigations, CRs, CAPAs & Floor Oversight Location: León (on-site)
Experience: At least 3 years’ experience in similar roles within the Quality department in pharmaceutical industrial settings

LEONFARMA is part of INSUD PHARMA, a integral leader in the pharmaceutical value chain and a benchmark in the research, development, manufacture and marketing of pharmaceutical products that contribute to human and animal health. Our purpose is to transform the industry through innovation, excellence and a commitment to sustainable development.

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

General Responsibility
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.

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

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