Quality manager

o	Ensure the revision and updating status of the Quality Management System;
o	Manage Quality Assurance resources;
o	Manage Quality Assurance processes;
o	Survey Quality Assurance’s Performance Indicators;
o	Manage Supplier Qualifications: Analyse and compile received documentation, analyse technical agreements, conduct audits;
o	Audit management: Conduct internal and external audits and plan/control of subcontracted audits;
o	Verify that processes are in legal compliance, in accordance with Good Manufacturing Practices and that fully and objectively reflect the actions performed;
o	Control and manage quality documents;
o	Ensure the handling of deviations, complaints and occurrences;
o	Ensure that the annual product review is conducted;
o	Follow the implementation of corrective, preventive and improvement actions, ensuring the registration of developed actions;
o	Ensure training for the implementation of QMS’s procedures and processes;
o	Follow up change control procedures; 
o	Apply Risk Management principles when necessary;
o	Support all departments with Good Manufacturing Practices compliance and in the implementation of concerning processes;
o	Ensure the update of the: validation plans; training and qualification plans; calibration, maintenance and verification plans for equipment and installations;
o	Plan along with other departments, the qualification of the equipment and the facilities as well as validation processes.

o	Qualification Manager:
	Suppliers Qualification.
	Equipment Qualification.
	Facilities Qualification.
	Software Qualification.
o	Validation Manager:
	Manufacturer Process Validation.
	Cleaning Validation.
o	External Audits Manager:
	Performer and coordinator of audits of Finished Products manufacturers in accordance with the European Good Manufacturing Practices (EU – GMP), ICH Q9 e ICH Q10.
	Performer and coordinator of audits of Active Substance manufacturers in accordance with the EU – GMP and ICH Q7.
	Performer and coordinator of audits of Excipients manufacturers.
	Performer and coordinator of audits of Packaging Materials manufacturers.
	Performer and coordinator of audits of Raw and Packaging Materials suppliers in accordance with the European Good Distribution Practices (EU-GDP).
o	Manager and performer of internal audits.
o	Representative of Laboratórios Basi in Grupo ISO.
o	Elaboration of Product Quality Review reports (PQR).
o	Revision of technical agreements.
o	Coordination and management of several Licensing processes. 
o	Internal trainer regarding GMP, GDP and internal procedures.
o	Control of the system documentation life cycle and its distribution.
o	Follow-up of corrective and preventive action.
o	Ensure the compliance with the Good Manufacturing Practices, Regulatory information and Internal Procedures. 

Specialist in Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Quality Management and ISO 9001:2008.
o	GMP Auditor of manufactures of Finished Product, Active Pharmaceutical Ingredients (API) and Pharmaceutical Excipients. 
o	Internal Auditor of quality management systems according to ISO 9001:2008, ISO 13485:2003, EU-GMP and ICH Q10.
o	Implementer of quality management systems according to ISO 9001:2008, ISO 13485:2003, ICH Q10 and EU-GMP in several pharmaceutical industries and distributors of medicinal products and medical devices.
o	Co-coordinator of the internal quality management system. 
o	Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) trainer of several pharmaceutical industries and distributors.
o	Project manager of Cleaning Validation Programs.
o	Cleaning Validation Trainer.
o	Elaboration of Qualification and Validation Protocols.
o	Elaboration of Validation Reports.
o	Elaboration of Product Quality Review Reports (PQR).
o	Elaboration of other Quality Technical Documentation, namely procedures, protocols, reports, quality manuals, and others. 
o	Documental Review, including translations and adaptations.
o	Deep Planning Knowledge with utilization of Gantt tool.
o	Support several pharmaceutical industries and distributors Licensing Processes, being the connecting link between customers and the Portuguese National Authority of Medicines and Health Products, INFARMED, I.P.
o	Expert Opinion in many subjects concerning medicines Manufacturing, Quality Control, Quality Assurance and Distribution.

o	Continuous Contact with Kaizen Institute.
o	Knowledge in 5S, SMED, TPM, OEE, Kobetsu Kaizen and Gantt.
o	Responsible in the manufacturing problems detection, resolution, implementation of continuous improvement tools and corrective/preventive actions and monitoring.
o	Responsible in the collection of manufacturing indicators and its presentation: production volume, rejection rate, number of hours of the machine turned on, stopping times.
o	Presentation of the manufacturing mensal results to the administration. 
o	Performing internal audits.
o	Basic maintenance knowledge, namely machine operating and assembling.
o	Packaging supervision, being the direct substitute of the packaging director.
o	Project manager of the Packaging Operators Training.

o	Control of all production processes of medicines since its manufacturing until its release.
o	Performing all required tests of moisture content determination or Loss on Drying, Density and Granulometry of granules or final blends, determination of the Individual and Average Weight of tablets and capsules, as well as its Thickness, Diameter, Width, Length and Hardness and its Friability and Disaggregation tests. 
o	Visual Inspections of the finished product and bulk.
o	Batch Records review.
o	Validation Reports elaboration.
o	Environmental monitoring.
o	Cleaning Validation Process.
o	Manufacturing and packaging supervision in the absence of manufacturing and packaging supervisors.
o	Continued involvement in other department issues, namely quality control, manufacturing, packaging and technical direction.
o	Advance Knowledge in computerised systems, namely SAP (management software) and Achiever (documental management system).

o	Batch Records review.
o	Retention Samples Inspection.
o	Execution of validation reports of new products and products or process that were changed.
o	Analyse of deviations and complains evaluation.
o	Cleaning validation process and environmental monitoring manager.
o	Continued involvement in other department issues, namely quality control, manufacturing, packaging and technical direction.

o	Manage a team of Quality Officers and directly replace them in case of absence;
o	Ensure the correct and timely handling of Change Controls opened for the 4 manufacturing units and actively participate in the impact assessment, definition of change plan, approval of change plan, approval of all change actions execution and final approval;
o	Follow the implementation of change actions;
o	Ensure the correct and timely handling of Deviations of the 4 manufacturing units and actively participate in the investigation, definition of corrective and preventive actions plan, approval of the execution of the corrective and preventive actions and final approval;
o	Follow the implementation of corrective, preventive and improvement actions;
o	Ensure the correct and timely handling of Complaints addressed, participating in the investigation and in the definition of corrective and preventive actions plan;
o	Manage the Quality Indicators of the Quality Assurance Operations;
o	Manage the Key Performance Indicators of the Quality Assurance Operations;
o	Perform Quality Audits (Internal and External);
o	Perform Risk Analysis;
o	Perform the trimestral suppliers monitoring report;
o	Work with some quality software (KabiTrack – Trackwise, gCMW, Q-Unit server) and with SAP ERP System;
o	Ensure training for the implementation of QMS’s procedures and processes;
o	Verify that processes are in legal compliance, in accordance with Good Manufacturing Practices and that fully and objectively reflect the actions performed;
o	Support all departments with Good Manufacturing Practices compliance and in the implementation of concerning processes.

Masters in Pharmaceutical Sciences