QA Specialist - Complaints & CAPAs (León site)

Chemo; Castilla y León; Presencial; EUR 42.000 - 64.000; Jornada completa

Descripción de la vacante

Chemo León is seeking an experienced Quality Assurance professional to ensure GMP compliance, regulatory alignment, and internal standards across site operations. You will manage complaints, CAPAs, investigations, document control, and support audits and inspections with a focus on EU & US GMPs.

The ideal candidate holds a degree in Pharmacy, Chemistry, or Sciences, has 3+ years in a similar QA role, and is fluent in English and Spanish.

Descripción del empleo

Site Name: Chemo León.

Global 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 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.