Site Name: Chemo León.

General Responsibility

Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization. Complaints and CAPAs management, returns, recalls, and site services compliance in accordance to internal procedures, GMPs rules, Authorities and customers requirements, among other tasks of the area. Site services compliance in accordance to internal procedures, GMPs rules, Authorities and customers requirements. EU & US GMP compliance.

Specific Responsibilities

Develop standard operating procedures (general quality and departmental) to ensure that the steps are collected in each case and comply with internal and external regulations applicable in each case.
Manage of complaints according to internal procedures complaints. Complaints records, analyses, risk assessment and resolution of complaints. Complaints archive and classification
Review and coordinate with other Departments the investigation of the complaints. Identification of root causes and responsibilities.



Follow up of related corrective/preventive actions.
Corrective and Preventive Actions (CAPAs) Management.
Support external audits and inspections according to the Annual Plan to assess the quality of the GMP system.
Support to the qualified person.
Support on quality investigations. Review and approved internal SOPs.
Management of GMP documentations and related archive.

Requirements and personal skills

Education: Degree in Pharmacy or Chemistry or Sciences.
Languages: Intermediate or high level of English required and bilingual in Spanish.
Experience (years/area): A minimum of 3 years’ experience in similar position.
Specific Knowledge: Knowledge of EU & US GMPs, quality systems (Complaints, CAPAs) in pharmaceutical companies. Experience in Quality Assurance, SAP Management, Office system, Trackwise.
Personal skills: Good communication skills, proactivity, good working under pressure, problems-solving, good organ

📌 QA Specialist (León)
🏢 Chemo
📍 León