QA Specialist - Complaints & CAPAs (León site)

Chemo; León; Presencial; EUR 42.000 - 63.000; Jornada completa

Descripción de la vacante

Laboratorios Leon Farma / Farmalan in Spain seeks a Quality Assurance professional to assure GMP, regulatory and internal standards. You will oversee complaints, CAPAs, returns, recalls, and site service compliance with internal procedures, GMPs, authorities and customer requirements. The role also involves SOP development, investigations, audits support, and maintaining GMP documentation and archives. Excellent organization, communication, and problem-solving are essential.

Formación

• Degree in Pharmacy, Chemistry or Sciences.
• English at intermediate or high level; Spanish bilingual.
• At least 3 years' experience in a similar QA/regulatory role.
• Knowledge of EU and US GMPs and CAPA systems (Complaints).

Responsabilidades

• Develop and maintain standard operating procedures to ensure regulatory compliance.
• Manage complaints, CAPAs, returns and recalls per procedures.
• Coordinate investigations with departments and identify root causes.
• Support external audits and inspections and assist the Qualified Person.
• Maintain GMP documentation and archives.

Conocimientos

Good communication

Proactivity

Problem solving

Organizational skills

Educación

Degree in Pharmacy or Chemistry or Sciences

Herramientas

SAP Management

Trackwise

Office suite

Descripción del empleo

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 organizational skills and persistent.

COMMITMENT TO EQUAL OPPORTUNITIES

Laboratorios Leon Farma / Farmalan is committed to equal opportunities.

We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.