Winnia Furtado

A proficient, versatile, focused and results-driven professional with a track record of 14+ years in pharmaceutical industry within the areas of Quality Assurance, Computer System Validations (CSV), Quality Audits, and consulting. A highly motivated energetic Associate Director seeking a dynamic management position where expertise in organization, attention to detail, and knowledge gained from pharmaceutical and consulting backgrounds can be effectively utilized across Pharmaceutical and Life Science industries to benefit the organization. Diligent professional with a strong work ethic, adaptability, exceptional interpersonal skills, and skilled at thriving in independent work environments.

• Awarded the “I am exceptional Intellectually Stimulating Individual award” for SAP Validation project for maintaining clarity of thought and managing client expectations as well as team.
• Awarded the “I am exceptional Entrepreneurial Individual award” for leading the CSV pursuits and engagements and for being a key in increasing the CSV solution.
• Awarded the “I am exceptional Entrepreneurial Team award” for outstanding work performed on SAP validation project for a pharmaceutical company in Bangladesh.
• Awarded the ‘EY KUDOS award’ for exemplary performance for 21 CFR Part 11 Assessment at a leading pharmaceutical manufacturing plant (2018).
• Awarded the ‘Jaagruti Star-Building tomorrow’s CIPLA’ for outstanding performance and valuable contributions (2014).
• Achieved Dr. K.U Naram award for securing the Third position at the final year examination of PG Diploma in Quality Assurance from the Association of Food Scientists & Technologists, Mumbai Chapter (2009).
• Received a Special Academic Achievement Award at Diploma Conferring Ceremony at Sophia College (2009).
• Awarded the ‘Jaagruti Star-Building tomorrow’s CIPLA’ for outstanding performance and valuable contributions (2014).
• Achieved Dr. K.U Naram award for securing the Third position at the final year examination of PG Diploma in Quality Assurance from the Association of Food Scientists & Technologists, Mumbai Chapter (2009).
• Received a Special Academic Achievement Award at Diploma Conferring Ceremony at Sophia College (2009).

• Conducting GLP Quality Audits, Data integrity investigations, Gap Assessments, GxP and Risk Assessments.
• Preparing protocols and review of Qualification documents of instruments.
• Qualifying instruments/applications in line with Computer System Validation (CSV), CSV executions and review.
• Knowledge about Deviations, Change controls and CAPA.
• Monitoring and review of laboratory activities in accordance with GLP (Good Laboratory Practices), preparing SOPs (Standard operating procedures) and ensuring complete implementation.
• Facing internal audits and backend preparations for external regulatory audits as well as local FDA.
• Evaluating the significance of audit findings and delivery of timely responses with implementation of corrective action.
• Review of personal validations and calibration reports.
• Preparation and monitoring of calibration schedules.
• Co-ordination with Third party for calibrations and Service engineers for installations.

• English
• Hindi
• Konkani

• Painting
• Designing
• Quilling
• Reading
• Listening to music

• Trained for a period of two months at Cipla Ltd, Goa (1st August - 30th September 2009).
• Trained for a period of two months at K.C.Engineering Corporation, Pastonji, Ice cream, Mumbai (15th May-14th - July 2009).
• Four-week training at Public testing Laboratories located in Mumbai.