Quality Assurance& Reg Affairs Coordinator
Design and implementation of the Quality System of the organization
Design and implementation of an operational documentary platform
Detalles de la empresa
International pharmaceutical company
Descripción de la vacante
Design and implementation of the Quality System of the organization to comply with the legal, regulatory and corporate requirements applicable to the importation and commercialization of health supplies (medicines).
Design, development and implementation of an operational and administrative documentary platform related to the import and storage activities of health supplies.
Prepare the documentation related to Quality Assurance and Control (Standard Operating Procedures (PNO), Quality Specifications, Analytical Methods, Quality Manual, Master Validation Plan, protocols and reports of Stability Studies, protocols and reports of Validation of Analytical methods).
Program and planning of all activities related to the analysis and release of finished product (Preparation of sampling plans, analysis, monitoring of activities of the analysis laboratories and opinion of finished product quality, as well as the management to acquire inputs used in these activities).
Stability Studies Administration. (Design, issuance, review of protocols and reports of stability studies, as well as the monitoring of activities during the study).
Administration of Analytical Technology Transfer studies (Design, issuance and review of Transfer Protocols and Reports, technical support during the development of transfers, programming of transfer activities).
Attention to internal and external audits (reception and implementation of corrective and preventive action plans to close nonconformities)
Perfil del candidato
Bachelor´s degree in Health sciences / similar
Between 3 and 5 years' relevant pharmaceutical regulatory experience
Oferta de empleo
Interesting opportunity in the Pharmaceutical Industry Sector for a recognized international company