Especialista, quality assurance

 Management of quality assurance and quality management activities in line with company ́s policies, procedures and practices, and all legal and customer requirements.
 Contact person with all the customers for all the quality matters regarding product management – APIs and Finished Product (about 90 active customers)
 Responsible for third parties (suppliers and outsourced companies) qualification and continuous and periodic evaluation
 Responsible for the management of Complaints, internal Deviations and CAPA.
 Responsible for the management of Change Controls
 Responsible for the preparation and disclosure of the Quality Management System policies and procedures.
 Responsible for the training on QMS.
 Monitoring and analysis of the Quality Management System key performance
indicators and responsible for the continuous improvement
 Responsible for the customer qualification and evaluation of customer
satisfaction
 Customer support to qualify Helm as a supplier
 Responsible for the good distribution practices of medicinal products and APIs
for human use
 Internal auditor to the Quality Management System and to the warehouse of
medicinal products and APIs for human use.

To provide support to QP in order to assure its Pharmaceutical Responsibility to fulfil local legislation and regulation, on local product release to market (of products not only from Sanofi Pasteur GBU portfolio but also from all the remaining GBU’s);
 To support CQH in the implementation and maintenance of an appropriate Country Quality System, in compliance with Sanofi Quality Policy, Quality Directives & Standards and regulatory requirements, concerning GxP activities related to development, manufacturing, distribution and commercialization of all products developed and/or marketed in the country by Sanofi;
 To ensure continuous audit and inspection readiness of the affiliate. Assure support on the execution of the annual audit plan;
 To manage deviations and CAPAs related to all GxP and health-regulated activities including those related to audits and inspection findings, across the country. Assure support in the management of Product Complaints and Quality Events (product recalls), according to Sanofi processes, standards and appropriate tools in force, in connection with the concerned Global Quality functions;
 To manage the changes that may impact GxP or health regulated process or operations by leading multidisciplinary exchanges and action plans when necessary;
To ensure that a process for management of GxP documents and records is in- place, in-use and up-to-date at country level for GxP areas;
 To manage the Country Quality Agreements (with the country as contract giver) for all GDP/GMP activities under the responsibility of Quality within the country organization;
 To ensure an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities;
 To organize and manage information sharing, training sessions or programs
related to processes owned by the CQH for concerned country associates, according to Sanofi standards and regulatory requirements.

 To assure cGMP compliance in all activities related to qualification and validation of systems/equipment and manufacturing processes. To coordinate and coach QA, Engineering, Maintenance and Manufacturing areas, promoting a continuous improvement culture and compliant with the applicable regulations and approved procedures;
 To participate in the management of Quality Systems key activities related to the previous topic. Quality Systems tools, Quality Systems Management (Docstream, CAPA, Change Control etc), Procedures and Policies, cGMPs training, Pest Control and other subcontracted services (such as preventive maintenance of clean rooms);
 To prepare/review/approve Quality Systems methodologies related to the area objectives and assuring adequate training for the Company Sites;
 To assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible or in which participates;
 To establish qualification/validation related procedures and documents to be followed;
 To perform internal or external audits and be present at customer audits;
To control deviations, CAPA, improvement plans and change control related to Qualification and Validation of Systems.

To manage Deviation investigation, CAPA System and Customers Technical Complaints; and Market Recalls;
 To respond to Health Authorities Quality notifications;
 To prepare & follow-up of Inspections and Second party audits and respective CAPA Plan;
 To prepare/review/approve documentation regarding Manufacturing Process Validation; Facilities, Systems/
Equipment and Utilities Qualification; Software Systems Qualification
 To assure cGMP/ Regulatory requirements compliance in all industrial processes/ activities;
 To review Batch Manufacturing/Packaging Records;
 To prepare/review/approve Product Quality Review reports;
 To manage Change Control System;
 To prepare formal Risk Assessments;
 To perform Personnel Integration and Training;
 To Administrate e-Software Application–Qpulse ®;
 To prepare/review/approve Standard Operational & Technical Procedures;
 To manage Document Management System;
 To manage Pest-Control and follow-up of HSEE audits.

Principles, system implementation and process improvements; Quality Risk management techniques; Process Analysis and tools for practical failure investigation, Deviation handling and classification, Root-cause investigation and CAPA system management, Deviations in the light of inspections, International Requirements and Regulatory approaches, Software tools for CAPA, KPI-Evaluation & Monitoring effectiveness of CAPA.

Auditor Training Course: auditing of quality management systems against the ISO 9001 standard, planning and preparation of audits, audit techniques, and audit reporting. Solid foundation on the ISO 9001 standard, the ability to interpret and implement requirements, and the skills and techniques to measure the effectiveness of a quality management system through an internal audit. Certificate no. 0601/2014.

Auditor Training Course: Quality Audit Good Practices on the ISO 19011 standards. Planning and preparation of audits, audit techniques, and audit reporting. Introduction to ISO 9001 and ISO 14001 standards. Final grade of 20 out of 20 values. Certificate no. 359/2014.

Internship in Community Pharmacy, within the discipline of '' Internship '' under the guidance of Dr. Paulo Monteiro, Technical Director and Owner of Pharmacy São José, Unipessoal, Lda, Coimbra , Portugal.Final grade of 19 out of 20 values.Thesis theme “Oxysterols: State of the Art and Future Prospects” within the discipline '' Pharmaceutical Monitoring '' under the supervision of Mrs Professor Doctor Maria Luísa Sá and Melo, in the Faculty of Pharmacy, University of Coimbra. Final grade of 18 out of 20 values.