Diretor qualidade em alenquer

- Act as Local Safety Responsible Person
- Management of product safety information;
- Responsible for collection, management and report of all adverse events occurring in Portugal and associated with Roche drug products;
- Interaction with the Health Authorities and Health Care Professionals on product safety-related matters;
- Responsible for Local Risk Minimization Plan Implementation 
- Responsible for ensuring pharmacovigilance requirements in local post-trial access programs (SDEA revision, support treating physicians and local Clinical Operations team).
- Ensure Quality Management System (Quality Management Reviews, KPIs, Quality Manual, Annual Quality Plan, Documentation, Audits, Training, Archive, Change Control, CAPA, Deviations, Quality Compliants, Returns)
- Management of medical inquiries response according to legal requirements and established Roche KPIs 
- Manager (7 people) and budget management

-Batch certification of commercial products and Investigational Medicinal Products (IMPs) 
-Contact with the Health Authorities and Health Care Professionals on product quality-related matters 
-Oversight of GMP/GDP Sub-contract activities at Rangel, Recipharm and Ambimed 
-GxP Quality Management System Harmonization (GCP/GVP/GMP/GDP Roche requirements)
-Implementation of Risk Management approach applied to distribution of commercial and IMPs
-Ensure Quality Management Reviews and Quality Audits
-Quality Management System-related activities oversight (KPIS, Core Compliance Metrics, Documentation Management, Training, Archive, Risk Management, Global Audits, Infarmed Inspections) 
-Manager (2 people) and budget management 
Special Project:
Regional Quality Leader for Region Europe - short term assignment F. Hoffmann-La Roche AG – Basel (Jan 17 – Mai 17)
-AOM (Affiliate Operating Model) project team member 
-RMCO (Regional Medical Compliance Office) 4 pillars member: Regulatory, Safety, Quality, Clinical Operations - Affiliates support for Region Europe 11 in GCP/GVP Roche Quality requirements 
-Affiliate Passport task force member 
-LQR (Local Quality Responsible) on boarding F2F trainer (Basel, April 2017) 
-Cross-Functional (Regulatory, Safety, Quality, Clinical Operations) meeting organization  (Budapest, May 2017)

SERIALIZATION – Working with the project leader, my role was to provide with Quality perspective to the implementation of the safety features in order to be compliant with Falsified Medicines Directive.

COLD CHAIN IMPROVEMENT – Responsible for the implementation, together with Warehouse and Logistics, of the new approach of cold chain (active system (Roller) instead of passive system (cold boxes), with great benefits from the financial and environment perspective.

BUSINESS CONTINUITY MANAGEMENT – As Project Leader, my role was lead the core team in order to develop Business Continuity Manual to minimize the impact of a disruption, to guarantee the capability of the organization to continue the delivery of key products and services at a minimum and acceptable level following a disruptive incident. 

QMS (Quality Management System) – Project Leader of this challenge: implementation at local level of a GCP/GVP Quality System aligned with the GMP/GDP Quality System already in place. A GxP Quality System was implemented at Medical Department.

QUALITY RISK MANAGEMENT – As Project Leader, I was responsible for the implementation of a Risk Management Process applied to Roche Processes, GMP sub-contractor supplier (Recipharm) and GDP sub-contractor supplier (Rangel).

Simpler@Roche – Representing Medical Department in the project team, the goal was to achieve the business processes Simplification of the whole Company, with reduction of the flow time and increasing flexibility. For the first time, a roadmap of all Roche processes and respective accountabilities was defined.

-Batch certification of commercial products and Investigational Medicinal Products (IMPs) 
-Local batch release activities of Commercial Products and Investigational Medicinal Products 
-Ensure GMP/GDP Quality Management System (Deviations/CAPA/Audits/Risk Management/Returns/Change Control/ Documentation/Training/Archive)
-Sub-contract activities and KPIs monitoring (Rangel, Recipharm, Prolixo) 
-Regulatory Change Management 

-Ensuring GDP/GMP compliance / ISO 9001 certification 
- Primary contact to the Health Authorities (Infarmed and DGV) 
- Contact with Technical Directors on Regulatory, Pharmacovigilance and Quality matters - Member of the international board 'DHL Healthcare Quality Team" 
- Member of the local Quality Group (responsible for the integrated Quality Management System in DHL) 
- Manager (2 people)

- Ensuring GMP compliance guidelines (primary and secondary packaging) 
- Complexity Reduction Project (Packaging Automation)
- Manager of a production team (80 operators)

- Application and maintenance of product Marketing Authorizations 
- Revision approval and change control of packaging materials 
- Support of product related questions

SPECIALIST OF PHARMACEUTICAL INDUSTRY, License by the Portuguese Board of Pharmacists (specialist n. 485)
Ordem dos Farmacêuticos

POSTGRADUATE OF  PHARMACEUTICAL INDUSTRY
Faculty of Pharmacy – University of Lisbon, Portugal

PHARMACEUTICAL SCIENCES Academic Degree	
Faculty of Pharmacy – University of Lisbon, Portugal

MASTER OF PHARMACEUTICAL SCIENCES (MPharm) – Thesis “Packaging Migration: Risks&Values”	
Faculty of Pharmacy – University of Lisbon, Portugal

eMBA – Executive MASTER BUSINESS ADMINISTRATION
INDEG ISCTE, Lisbon, Portugal