Bruna Merli

Leadership of team of 4 quality analysts. The team develops activities of document control, validation, audits, training, change control, investigation of internal deviations, complaints, GMP, integrated management systems, elaboration of management review reports. Coordination of customer visits and participation in 6 sigma lean improvement projects. International experience – China (10/2013 - 11/2013)

Quality assurance analyst in primary pharmaceutical packaging industry with focus on document control, validation, audits (internal, third part certification, customer and supplier), SOP development, training, internal deviations/complaints investigation, GMP, integrated management systems (ISO 9001, ISO 14001, ISO 15378 and OHSAS 18001), reporting on management review and participation in lean 6 sigma improvement projects.

QA analyst in the sterile and non-sterile drug industry focusing on creation of SOPs, validation and qualification protocols, monitoring of the purified water (PW) and water for injection (WFI) system, environmental monitoring of certificated areas, preparation and execution of training, monitoring and investigative process of complaints and nonconformities, basic knowledge in microbiological analysis and physicochemical properties.