Descripción de la oferta
## QA SPECIALISTSolicitarremote type:Industrial Operationslocations:SANT FELIU DE LLOBREGAT:SANT ANDREU DE LA BARCAtime type:Full timeposted on:Publicado hace 5 díastime left to apply:Fecha final: 31 de julio de 2026 (Quedan 18 días para realizar la solicitud)job requisition id:001568Estamos construyendo el futuro de la dermatología médica centrándonos en las necesidades no cubiertas de los pacientes y dando a las personas el espacio para pensar de forma independiente, asumir responsabilidades y generar un impacto que de verdad importe.Nuestro propósito es sencillo: transformar la vida de los pacientes abordando necesidades reales. Trabajamos con rigor, actuamos con valentía, simplificamos lo complejo y enfocamos la innovación allí donde realmente marca la diferencia.Reconocidos como Top Employer en España desde 2008 y en Alemania desde 2025, seguimos invirtiendo en un entorno donde las personas pueden crecer y avanzar.Si quieres hacer las cosas de otra manera, este es tu lugar.**Mission**To support the maintenance, development and continuous improvement of the Almirall GVP Quality Management System ensuring compliance with applicable regulations and guidelines.**Responsibilities****1.** To support the QA GVP Senior manager in maintaining the Quality System for Pharmacovigilance activities in accordance with Almirall policies, ICH guidelines, EU GVP modules, and other relevant regulatory requirements with the support of the Almirall Corporate Patient Safety department.**2.** To cooperate in the setting up of the GVP risk-based audit plan and program and in performing (or coordinating and overseeing when outsourced) audits on a regular basis.**3.** To report the audit observations arising from audits (or any other quality issue) to applicable management and follow-up on the significant findings until completion.**4.** To help in the preparation and management of inspection by Competent Authorities and audits by third parties to Almirall by developing an inspection readiness plan.**5.** To drat the procedures applicable to QA Drug Safety and any other key documents ensuring that they are aligned and compliant with the applicable regulation.**6.** To contribute in selecting, coordinating and overseeing the outsourced QA activities applicable to pharmacovigilance (e.g. audits, mock inspections, training).**9.** To support the Pharmacovigilance audits to the Almirall Pharmacovigilance system including processes, partners and CROs at both corporate and affiliate level.**Education**Life Sciences degree**Specific expertise**-Knowledge of drug safety, data management, and statistics.-IT systems skills.-Awareness of EU and non-EU regulations applicable to pharmacovigilance.-Training in Quality Assurance, specifically R&D areas.- Proficiency in English languageCENTRO: R&D - Sant Feliu de LLobregatTIPO DE CONTRATO: TemporalGRUPO PROFESIONAL: 6HORARIO: Central FlexQA R&D & CPD - GVP Quality Assurance Specialist
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