Sanda Vilela

Professional profile
Entrepreneur leader with over 15 years’ experience in the pharmaceutical industry (both private and public sector) offers expertise in GxP environment and people management to support the companies Vision and Mission

Skills
Leadership, Conflict Resolution, Problem-solving and Resourcefulness, Confidence, Flexibility, Team
Player, Time Management, Lean 6 Sigma, Quality Systems, GxP, ISO 9001, ISO 14001, ISO 45001,
ISO 17025

Career summary
Sofarimex - Ind. Química e Farmacêutica, S.A. Sept. 2020 - Present
Quality Director & Q.P.
Lead the Quality Unit team - Quality Assurance and Quality Control (around 60 people) assuring business goals are met in line with applicable Regulations and Customers expectations.
Key Responsabilities
- Coordinate all Quality Assurance and Quality Control activities (routine and projets)
- KPI definition and Reporting
- Manage CAPEX and OPEX
- Coordinate Customers and Authorities Audit Plan
- Continuous improvement of all on-site quality related activities

VIFOR PHARMA, Lisboa May 2013 – Sept. 2020
Quality Control Manager 
Lead the Quality Control Chemical and Microbiological team (15 people) assuring compliance with applicable
Regulations and simultaneously establishing methodologies that meet the current scientific knowledge and are in
line with the guidelines and objectives set by the company.
Key Responsabilities
- Develop and motivate people: mentoring and conflict management
- Manage CAPEX and OPEX
- Monitor the unit´s performance (KPI plan)
- Coordinate all in house and subcontracted QC activities: raw material, packaging material, finished product
inspection, sampling, testing and release for over 50 different countries; environmental and PW monitoring; stability
plan; analytical method validation and transfer
- Support to different business areas/project management
- Supervise Document issue and review, Change Controls, CAPA plan, OOS investigations and Deviations related
with the functional area
- GMP and GDP auditor
Key achievement/projects
- Establish a mid-term plan to leverage the technical level of the laboratory: team, facilities and equipment
- Coordinate the construction and set up of a new laboratory and support the construction and set up of a new
pharmaceutical facility

INFARMED, I.P., Lisboa February 2006 – May 2013
Quality Specialist 
Assure as Quality Specialist different roles related with the National Authority’s mission both in its national and
international areas of expertise
Key Responsabilities
- Represent the National Authority in European working groups, namely EDQMs "Official Cosmetics Control
Laboratories - Committee of Experts on Cosmetic Products (P-SC-COS)," and "Unlicensed Pharmaceutical
Preparations"
- Analytical activities in the Pharmaceutical and Chemical unit related with Drug Product, Raw material and Cosmetic
analysis
- Experienced laboratory technician (HPLC-DAD, HPLC-FLUO, GC), pharmaceutical techniques and other classical
analytical techniques