Tharcila Moratori
Validation Lead @Kedrion Biopharma
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WORK HISTORY
Validation Lead @Kedrion Biopharma
Elstree, GB
In my role as Validation Lead at Kedrion Biopharma, I am responsible for the preparation, execution, and reporting of process validation, as well as overseeing and supporting any other validation activities i.e. cleaning, media fills, equipment validation. I also serve as the Subject Matter Expert for process validation, reviewing and approving GMP and validation documents and make sure we are compliance with regulatory guidelines. Additionally, I participate in several team project meetings as SME and FMEA/QRA meetings to assess project risks with other stakeholders. I also am responsible for preparing SOPs and policies related to validation activities and the review of SVMP.
EDUCATION
King's College London
Master's degree, Clinical Pharmacology
Centro Universitário FMU | FIAM-FAAM
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
SKILLS
ABOUT THARCILA MORATORI
Currently working as Validation Lead in biological manufacturing site for sterile products. Wide GxP experience, and QMS experience. Strong communication and organisation skills. Extensive experience in the pharmaceutical industry within Quality Assurance. Masters in Clinical Pharmacology at Kings College London. Interested in biotechnology therapies and clinical research experiences. Good knowledge of clinical trial documentations and guidances.
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