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

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

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Location: León (on-site)

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

Want to find out more?

LEONFARMA is part of INSUD PHARMA, a global 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.

Ready to be a #Challenger at LEONFARMA?

What are we looking for?

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.

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
• Effective communication
• Compliance, integrity and sustainability
• Growth mindset
• Business focus

Our benefits!

Permanent contract

Career progression and development within a growing international group

Ongoing training and an innovative working environment

Subsidised canteen and other employee benefits

What will the recruitment process be like?

Initial contact by phone or email with our Talent Acquisition team. 1 or 2 face-to-face interviews at our premises in León. Regular updates on the progress of the process.

Do you think this role isn't for you?

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