Evaluates incoming complaint information and maintains the record in the electronic database. Performs follow up activities to obtain additional information.
Use and maintain database(s), provide analysis and trending data all on complaints. Determines reportability of complaints to Government Agencies.
Identify and document appropriate complaint categories to assure trend accuracy within the complaint database. Ensures record documentation is maintained in a constant state of audit readiness per internal policies.
Liaison with groups who perform additional investigation and who prepare written record of investigation. Interact with Technical Service, Manufacturing, RD, and Quality Control, as needed, during the course of complaint processing.
Provide basic technical expertise and assistance in handling complaints to comply with current Anvisa and International reporting regulations.
Reviews and interprets risk management documentation as it applies to the complaint event. Manages the creation, development / review and approval of changes to quality documents, such as procedures, Work Instructions and Job Aides.
Follow-up on Corrective and Preventative Actions (CAPA) and related tasks in Trackwise, coordinate with task owners to ensure timely completion of tasks.
Supports internal and external audits. Conducts quality awareness trainings as required. Collecting and coordinating flow of information for regular management reporting, related to the deployment of QMS content.
Development of QMS related content to be deployed through the Learning Management System. Experience in medical or pharmaceutical industry.
Individual with a suitable college degree or other relevant experience may qualify. Experience in developing processes and documentation, including process diagramming.
Bachelors degree in relevant field required (i.e. engineering, life sciences). Conhecimentos : Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis an