Vaccines Quality Control Manager (Qc)

Global Responsibility:- Coordinate, plan and evaluate daily work of QC team (FQ and micro), following Company and department priorities as well as ICH standards, FDA regulations, cGMPs for active pharmaceutical ingredients, according to EU and US GMP regulations, and following European / USP Pharmacopeias- Supervision and coordination of the activities of the personnel assigned- Review, develop and approve internal SOPs, specifications and analytical methods- Establish and review the calibration and maintenance program of the analytical equipment assigned.- Actively participation in the investigation of Deviations and Investigations associated with the environmental controls of the manufacturing plant- Lead the investigation of OOS results associated with analytical controls and microbiological control of the products manufactured in the plant- Ensure that QC requirements meet the Quality System standards and ensure early detection of possible systematic errors, trends or Deviations in monitored systems/products/processes.- Organize and manage the stability studies of the productTechnical skills- Knowledge of regulations applicable to the pharmaceutical sector, focused on requirements applicable to chemical control laboratories: GMP standards, ICH, GAMP, Pharmacopoeias, among others.- Solid expertise in instrumental techniques associated with chromatography, spectrophotometry and chemical analysis. Solid knowledge in validation of analytical methods.Número de vacantes: 1Modalidad de trabajo: Presencial"**Requisitos**- English required: minimum English level C1 desirable C2 ( full proficiency).Estudios mínimosLicenciado**Idiomas**:Inglés nível Perfecto.- Experiência mínima5 añosDisponibilidad para viajarNinguna