Valencio Salema
Manager, Operational Quality- Vaccines (Diphtheria, Tetanus and Tuberculin Ppd) @Sanofi
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WORK HISTORY
Manager, Operational Quality- Vaccines (Diphtheria, Tetanus and Tuberculin Ppd) @Sanofi
To provide quality oversight and guidance to the Tetanus APT on aspects of shopfloor/operational activities. Responsible for timely and thorough deviation investigations, Root cause analysis, CAPAs to ensure any batch related decisions are science and compliance based. Participates in self-inspections, periodic internal reviews to ensure compliance is met. Supports any external health authority audits and inspections.
EDUCATION
University of Toronto
Postdoctoral fellow
Vellore Institute of Technology
Master of Technology
Universidad Autónoma de Madrid
PhD
Annamalai University
Bachelor of Business Administration - BBA
Smt.Parvatibai Chowgule Cultural Foundations College of Arts & Science Fatorda
10+2
American International University of Management and Technology (AIUMT)
Bachelor of Science - BSc
SKILLS
ABOUT VALENCIO SALEMA
At the heart of Sanofi\'s Vaccine operations, my focus as Manager of Operational Quality is upholding our products and practices to the highest standards of GMP. Leveraging my experience in Manufacturing sciences, process development, validation and Quality by design, I ensure that decisions are made based on sound scientific and quality risk management principles for our Diphtheria, Tetanus, and Tuberculin PPD vaccines. My role encompasses overseeing thorough deviation investigations, root cause analysis, and putting efficient CAPAs in place, which is pivotal in maintaining our commitment to our customers in terms of providing safe and efficacious live-saving medicines.My expertise is further demonstrated through active participation in self-inspections and during external health authority audits, ensuring our processes meet the stringent regulatory demands. The competencies gained in my previous role, where I managed process validation activities at the Sanofi Toronto site and provided technical guidance, are now instrumental in improving Sanofi\'s validation strategy and in maintaining impeccable quality oversight.
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