Ing. Ana Cardoso

• Manage QMS (quality management system) • Implementation of ISO 20387:2018 • ISO 9001:2015 • Perform risk assessment (FMEA) • roXtra • creation of SOPs • responsible for training employees

• Preparation of method validation documentation for a new product (FDA, Part 11).

• Plan and execution computer system validation (CSV) projects (FDA, Part 11) • Provide regulatory compliance and computer validation guidance/support • Create system validation deliverables (validation plan, user requirements, functional requirements, risk analysis, test protocols, validation reports) • Perform risk analysis (FMEA) • Plan and execute the validation testing • Creation and implementation of a QMS (quality management system) for pharmaceutical industries • Implementation of ISO 9001

• Responsible for planning, executing and evaluating new method transfer projects as well as process validation of analysis; • Generation, review and completion of documentation; • Ensure laboratory processes are carried out according to approved documents; • SAP Training;

• Responsible for execution / validation of new methods of analysis, documentation of results and generation of validations reports • Analysis domain on the following equipments: liquid chromatography (HPLC) , gas chromatography (GC), pH Meter, Karl-Fischer, Coulometric KF Headspace, Spectroscopic Methods (UV, IR).

• Introduction and knowledge acquirement on liquid chromatography (HPLC) , gas chromatography (GC) and chemical analysis; • GMP’s and GLP’s training;

• “Use of NIR spectroscopy technique associated with Refining Processes”; • Matlab™; • Knowledge acquirement on NIR spectroscopy, gas chromatography (GC) and mass chromatography; • Knowledge acquirement on chemical analysis and Research Octane Number (RON).