Palabras clave: Control de Contaminación, Esterilidad, protocolos de limpieza¿How about working in a company where research and development of biologics is the top priority?Vaxthera is a Colombian Biotechnology company that develops products and services that contribute to the health sovereignty of Colombia and the region, positively impacting people's health through prevention.What´s the main purpose of the role?Sterility Assurance Supervisor: Oversee the Contamination Control Strategy (CCS) for the sterile manufacturing site, including its development, implementation, and updates. Responsibilities include ensuring optimal environmental monitoring indicators, compliance with regulatory requirements, providing Sterility Assurance expertise to Operations, reviewing cleaning protocols, conducting risk assessments, establishing response plans for environmental events, and aligning policies with other departments to achieve company objectives.RESPONSIBILITIES:· Manage the Contamination Control Strategy (CCS) for the sterile manufacturing site: Development, implementation and updating.· Assure the adequate facilities contamination control practices monitoring tools are provided to production to guarantee the best environmental monitoring indicators levels, including trends analysis interpretation, challenge technical and scientific aspects of facilities design and aseptic principles with HR/ Admin, QA, QC and production.· Provide oversight and Sterility Assurance expertise to Operations to assure all applicable regulatory requirements are met.· Review, and/or approve environmental cleaning protocols to support cleaning practices.· Responsible for the microbiological/sterility assurance risk assessment.· Establish appropriate response plans to environmental events in clean-rooms.· Work with other departments to achieve company objectives and ensure policy alignment across site.What are we looking for?Professional GraduateProfessional in Sciences (Life Sciences), Chemistry, Pharmaceutical Chemistry, Biotechnology, Microbiology, Biochemistry or equivalentArea of expertise: INVIMA, USFDA guidelines, CGMP, QRM, QMS and Audits &Lenguage: English B2HabilidadesInglesEMA guidelinesUS FDAteam managementLiderazgoRequisitos para aplicar a la vacante:Experiencia:5 años de experienciaNivel de estudios:Profesional hasta Especialización/ MaestríaCiudad de residencia:Medellín - RionegroSalario:Salario a convenirAplicarCompartir vacante en:Empleos similares:Búsquedas de empleo más frecuentesVer Más (27)Síguenos:Magneto Global S.A.S, todos los derechos reservadosPersonasCrear cuentaMagneto CorporativosMagneto NegociosOtras solucionesLegalVinculado a la red de prestadores del Servicio Público de Empleo. Autorizado por la Unidad Administrativa Especial del Servicio Público de Empleo según