QA Specialist — Complaints & CAPAs (Pharma, GMP)

Chemo; León; On-site; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Subsidised canteen

Employee benefits

Job summary

Chemo in León, Spain, is seeking a QA Specialist for Complaints & CAPAs to ensure GMP compliance across the global supply chain. The role focuses on handling complaints, CAPAs, returns, recalls, and site services compliance in line with internal procedures, GMPs, and customer requirements.

You will develop standard operating procedures, manage complaint investigations, identify root causes, drive corrective actions, support external audits, and assist the Qualified Person.

Qualifications

• 3+ years in QA in pharmaceutical sector
• Experience managing complaints and CAPAs
• Knowledge of EU & US GMPs
• English intermediate or higher, Spanish bilingual
• Experience with QA systems and documentation control

Responsibilities

• Assure compliance of GMP, regulatory and internal standards
• Manage complaints, CAPAs, returns, recalls and site services compliance
• Coordinate investigations with other departments and identify root causes
• Lead corrective and preventive actions (CAPAs)
• Support external audits and inspections
• Assist the qualified person and review internal SOPs

Skills

Quality Assurance

SAP

Trackwise

Office Suite

Communication

Education

Degree in Pharmacy or Chemistry or Sciences

Tools

SAP

Trackwise

Office Suite

Job description

Chemo in León, Spain, is seeking a QA Specialist for Complaints & CAPAs to ensure GMP compliance across the global supply chain. The role focuses on handling complaints, CAPAs, returns, recalls, and site services compliance in line with internal procedures, GMPs, and customer requirements.

You will develop standard operating procedures, manage complaint investigations, identify root causes, drive corrective actions, support external audits, and assist the Qualified Person.