Vaga de Analista de Qualidade Pl - Posição baseada em Extrema - MG

Essential Functions Technical responsible Imported products release. Support on Warehouse and Distribution activities (temperature mapping, operational support, etc.) Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting. Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner. Support and track the implementation and maintenance of the local Quality system in accordance with the Alcon Quality Manual. Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management. Ensures that processes are conducted in full compliance with the GxP and the Alcon Quality. Contributes to an improvement of current processes and/or to an implementation of modified processes. Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), inc escalation of issue related to the closure of CAPA, as appropriate. Review quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments. Prepare and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentation. Provides support for regulatory and corporative audits. Leads internal and external audits, acting as a Qualified/Certified GxP Auditor. MDR  translation and implementation Manages medium to small level regulatory submissions, as CRF updates. Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain local products. Interprets and enforces all applicable legislations by following the appropriate escalation process. Requirements Active register CRF Bachelor degree in Pharmacy Fluency in English ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker